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| Name | Class |
|---|---|
| Ironwood Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linaclotide 290 micrograms | Experimental | Linaclotide 290 micrograms |
|
| Linaclotide 145 Micrograms | Experimental | Linaclotide 145 micrograms |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linaclotide 290 micrograms | Drug | oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder | A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline. | 12-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder | A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline. | 12-week treatment period |
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Inclusion Criteria:
Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings
Patient has successfully completed protocol procedures (with no clinically significant findings)
Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks:
Patient demonstrates continued chronic constipation and bloating through Pretreatment Period
Patient is compliant with Interactive voice response System (IVRS)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Shiff, MD | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 020 | Chandler | Arizona | 85224 | United States | ||
| Forest Investigative Site 102 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33428631 | Derived | Lacy BE, Shea EP, Manuel M, Abel JL, Jiang H, Taylor DCA. Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications. PLoS One. 2021 Jan 11;16(1):e0243318. doi: 10.1371/journal.pone.0243318. eCollection 2021. | |
| 26222318 | Derived | Lacy BE, Schey R, Shiff SJ, Lavins BJ, Fox SM, Jia XD, Blakesley RE, Hao X, Cronin JA, Currie MG, Kurtz CB, Johnston JM, Lembo AJ. Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial. PLoS One. 2015 Jul 29;10(7):e0134349. doi: 10.1371/journal.pone.0134349. eCollection 2015. |
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Enrolled participants had up to 21 days of screening (screening period) to determine eligibility for entry into the study's pretreatment period. After an additional 14 to 21 days of pretreatment, those patients meeting entry criteria were randomized for 12 weeks of double-blind treatment.
Patient recruitment occurred at 136 study sites in the US and 5 study sites in Canada over a 6 month period from August of 2012 to February of 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| FG001 | Linaclotide 145 Micrograms | Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Linaclotide 145 micrograms | Drug | oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
| Matching placebo | Drug | oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
| Change From Baseline in 12-Week Abdominal Bloating | Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period. | Baseline and 12-week treatment period |
| Percent Change From Baseline in 12-week Abdominal Bloating | Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period. | Baseline and 12-week treatment period |
| Percent Change From Baseline in Abdominal Bloating at Week 12 | Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12. | Baseline and Week 12 |
| 6/12 Week Abdominal Bloating 30% Responder | A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient's improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline. | 12-week treatment period |
| Change From Baseline in 12-week CSBM Frequency Rate | A patient's 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and 12-week treatment period |
| Change From Baseline in CSBM Frequency Rate at Week 1. | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 1 |
| Change From Baseline in CSBM Frequency Rate at Week 4. | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 4 |
| Change From Baseline in CSBM Frequency Rate at Week 8 | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 8 |
| Change From Baseline in CSBM Frequency Rate at Week 12 | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 12 |
| Change From Baseline in 12-Week SBM Frequency Rate | A patient's Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 12-week treatment period |
| Change From Baseline in SBM Frequency Rate at Week 1 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 1 |
| Change From Baseline in SBM Frequency Rate at Week 4 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 4 |
| Change From Baseline in SBM Frequency Rate at Week 8 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 8 |
| Change From Baseline in SBM Frequency Rate at Week 12 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 12 |
| Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM) | A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and 12-week treatment period |
| SBM Within 24 Hours After the First Dose of Investigational Product | The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 24 hours from first dose of investigational product (Day 1) |
| Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product | Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time). Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 12-week treatment period |
| Change From Baseline in 12-week Stool Consistency | Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):
A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and 12-week treatment period |
| Change From Baseline in Stool Consistency at Week 12 | Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):
A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 12 |
| Change From Baseline in 12-week Severity of Straining | Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and 12-week treatment period |
| Change From Baseline in Severity of Straining at Week 12 | Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | Baseline and Week 12 |
| 9/12 Week Mild Straining and Diarrhea-free Responder | A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 12-week treatment period |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Forest Investigative Site 149 | Glendale | Arizona | 85308 | United States |
| Forest Investigative Site 126 | Goodyear | Arizona | 85395 | United States |
| Forest Investigative Site 018 | Phoenix | Arizona | 85018 | United States |
| Forest Investigative Site 061 | Phoenix | Arizona | 85020 | United States |
| Forest Investigative Site 022 | Scottsdale | Arizona | 85251 | United States |
| Forest Investigative Site 079 | Tucson | Arizona | 85704 | United States |
| Forest Investigative Site 071 | Tucson | Arizona | 85712 | United States |
| Forest Investigative Site 135 | North Little Rock | Arkansas | 72117 | United States |
| Forest Investigative Site 106 | Anaheim | California | 92801 | United States |
| Forest Investigative Site 104 | Laguna Hills | California | 92653 | United States |
| Forest Investigative Site 066 | Mission Hills | California | 91345 | United States |
| Forest Investigative Site 095 | San Carlos | California | 94070 | United States |
| Forest Investigative Site 009 | San Diego | California | 92108 | United States |
| Forest Investigative Site 151 | Santa Monica | California | 90404 | United States |
| Forest Investigative Site 010 | Westlake Village | California | 91361 | United States |
| Forest Investigative Site 012 | Boulder | Colorado | 80304 | United States |
| Forest Investigative Site 041 | Colorado Springs | Colorado | 80904 | United States |
| Forest Investigative Site 045 | Colorado Springs | Colorado | 80907 | United States |
| Forest Investigative Site 060 | Longmont | Colorado | 80501 | United States |
| Forest Investigative Site 007 | Bristol | Connecticut | 06010 | United States |
| Forest Investigative Site 153 | Waterbury | Connecticut | 06708 | United States |
| Forest Investigative Site 091 | Boynton Beach | Florida | 33426 | United States |
| Forest Investigative Site 047 | Bradenton | Florida | 34208 | United States |
| Forest Investigative Site 042 | Brooksville | Florida | 34601 | United States |
| Forest Investigative Site 133 | Coral Gables | Florida | 33134 | United States |
| Forest Investigative Site 131 | DeLand | Florida | 32720 | United States |
| Forest Investigative Site 051 | Fort Myers | Florida | 33916 | United States |
| Forest Investigative Site 137 | Inverness | Florida | 34452 | United States |
| Forest Investigative Site 114 | Jacksonville | Florida | 32205 | United States |
| Forest Investigative Site 004 | Jupiter | Florida | 33458 | United States |
| Forest Investigative Site 016 | Kissimmee | Florida | 34741 | United States |
| Forest Investigative Site 097 | Lauderdale Lakes | Florida | 33319 | United States |
| Forest Investigative Site 003 | Miami | Florida | 33143 | United States |
| Forest Investigative Site 002 | Miami | Florida | 33183 | United States |
| Forest Investigative Site 130 | New Smyrna Beach | Florida | 32168 | United States |
| Forest Investigative Site 040 | Ocala | Florida | 34471 | United States |
| Forest Investigative Site 083 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 150 | Oviedo | Florida | 32765 | United States |
| Forest Investigative Site 132 | Port Orange | Florida | 32129 | United States |
| Forest Investigative Site 127 | Seminole | Florida | 33777 | United States |
| Forest Investigative Site 087 | St. Petersburg | Florida | 33709 | United States |
| Forest Investigative Site 064 | Tampa | Florida | 33606 | United States |
| Forest Investigative Site 115 | Zephyrhills | Florida | 33542 | United States |
| Forest Investigative Site 021 | Marietta | Georgia | 30060 | United States |
| Forest Investigative Site 011 | Marietta | Georgia | 30067 | United States |
| Forest Investigative Site 109 | Sandy Springs | Georgia | 30328 | United States |
| Forest Investigative Site 037 | Stockbridge | Georgia | 30281 | United States |
| Forest Investigative Site 023 | Woodstock | Georgia | 30189 | United States |
| Forest Investigative Site 015 | Idaho Falls | Idaho | 83404 | United States |
| Forest Investigative Site 122 | Peoria | Illinois | 61602 | United States |
| Forest Investigative Site 043 | Rockford | Illinois | 61107 | United States |
| Forest Investigative Site 107 | Anderson | Indiana | 46011 | United States |
| Forest Investigative Site 117 | Clive | Iowa | 50325 | United States |
| Forest Investigative Site 146 | Clive | Iowa | 50325 | United States |
| Forest Investigative Site 143 | Davenport | Iowa | 52807 | United States |
| Forest Investigative Site 055 | Iowa City | Iowa | 52242 | United States |
| Forest Investigative Site 028 | Newton | Kansas | 67114 | United States |
| Forest Investigative Site 112 | Overland Park | Kansas | 66215 | United States |
| Forest Investigative Site 034 | Wichita | Kansas | 67205 | United States |
| Forest Investigative Site 032 | Wichita | Kansas | 67207 | United States |
| Forest Investigative Site 128 | Lexington | Kentucky | 40509 | United States |
| Forest Investigative Site 134 | Madisonville | Kentucky | 42431 | United States |
| Forest Investigative Site 121 | Baton Rouge | Louisiana | 70809 | United States |
| Forest Investigative Site 124 | Metairie | Louisiana | 70006 | United States |
| Forest Investigative Site 101 | Monroe | Louisiana | 71201 | United States |
| Forest Investigative Site 058 | Shreveport | Louisiana | 71101 | United States |
| Forest Investigative Site 099 | Shreveport | Louisiana | 71103 | United States |
| Forest Investigative Site 062 | Baltimore | Maryland | 21215 | United States |
| Forest Investigative Site 008 | Chevy Chase | Maryland | 20815 | United States |
| Forest Investigative Site 014 | Hagerstown | Maryland | 21742 | United States |
| Forest Investigative Site 024 | Towson | Maryland | 21286 | United States |
| Forest Investigative Site 006 | Boston | Massachusetts | 02135 | United States |
| Forest Investigative Site 070 | Chesterfield | Michigan | 48047 | United States |
| Forest Investigative Site 145 | Traverse City | Michigan | 49684 | United States |
| Forest Investigative Site 141 | Jackson | Mississippi | 39202 | United States |
| Forest Investigative Site 077 | Fremont | Nebraska | 68025 | United States |
| Forest Investigative Site 048 | Omaha | Nebraska | 68134 | United States |
| Forest Investigative Site 052 | Henderson | Nevada | 89014 | United States |
| Forest Investigative Site 080 | Las Vegas | Nevada | 89121 | United States |
| Forest Investigative Site 036 | Clifton | New Jersey | 07012 | United States |
| Forest Investigative Site 088 | Marlton | New Jersey | 08053 | United States |
| Forest Investigative Site 033 | Vineland | New Jersey | 08360 | United States |
| Forest Investigative Site 063 | Albuquerque | New Mexico | 87106 | United States |
| Forest Investigative Site 093 | Albuquerque | New Mexico | 87108 | United States |
| Forest Investigative Site 044 | Brooklyn | New York | 11206 | United States |
| Forest Investigative Site 017 | Great Neck | New York | 11021 | United States |
| Forest Investigative Site 142 | Asheboro | North Carolina | 27203 | United States |
| Forest Investigative Site 094 | Asheville | North Carolina | 28801 | United States |
| Forest Investigative Site 075 | Boone | North Carolina | 28607 | United States |
| Forest Investigative Site 123 | Chapel Hill | North Carolina | 27599-7080 | United States |
| Forest Investigative Site 140 | Davidson | North Carolina | 28036 | United States |
| Forest Investigative Site 039 | Fayetteville | North Carolina | 28304 | United States |
| Forest Investigative Site 031 | Greensboro | North Carolina | 27403 | United States |
| Forest Investigative Site 029 | Greensboro | North Carolina | 27408 | United States |
| Forest Investigative Site 078 | Greensboro | North Carolina | 27408 | United States |
| Forest Investigative Site 084 | Harrisburg | North Carolina | 28075 | United States |
| Forest Investigative Site 073 | Hickory | North Carolina | 28601 | United States |
| Forest Investigative Site 050 | Hickory | North Carolina | 28602 | United States |
| Forest Investigative Site 139 | High Point | North Carolina | 27262 | United States |
| Forest Investigative Site 027 | Raleigh | North Carolina | 27612 | United States |
| Forest Investigative Site 119 | Statesville | North Carolina | 28625 | United States |
| Forest Investigative Site 089 | Wilmington | North Carolina | 28401 | United States |
| Forest Investigative Site 074 | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative Site 025 | Cincinnati | Ohio | 45242 | United States |
| Forest Investigative Site 120 | Cincinnati | Ohio | 45249 | United States |
| Forest Investigative Site 056 | Cleveland | Ohio | 44122 | United States |
| Forest Investigative Site 026 | Columbus | Ohio | 43215 | United States |
| Forest Investigative Site 098 | Dayton | Ohio | 45415 | United States |
| Forest Investigative Site 090 | Dayton | Ohio | 45432 | United States |
| Forest Investigative Site 085 | Mentor | Ohio | 44060 | United States |
| Forest Investigative Site 068 | Wadsworth | Ohio | 44281 | United States |
| Forest Investigative Site 118 | Oklahoma City | Oklahoma | 73104 | United States |
| Forest Investigative Site 081 | Levittown | Pennsylvania | 19056 | United States |
| Forest Investigative Site 001 | Pittsburgh | Pennsylvania | 15206 | United States |
| Forest Investigative Site 110 | Reading | Pennsylvania | 19606 | United States |
| Forest Investigative Site 116 | Greer | South Carolina | 29650 | United States |
| Forest Investigative Site 046 | Simpsonville | South Carolina | 29681 | United States |
| Forest Investigative Site 092 | Dakota Dunes | South Dakota | 57049 | United States |
| Forest Investigative Site 129 | Chattanooga | Tennessee | 37421 | United States |
| Forest Investigative Site 138 | Kingsport | Tennessee | 37660 | United States |
| Forest Investigative Site 125 | Austin | Texas | 78756 | United States |
| Forest Investigative Site 035 | Dallas | Texas | 75231 | United States |
| Forest Investigative Site 005 | Dallas | Texas | 75234 | United States |
| Forest Investigative Site 111 | Fort Worth | Texas | 76135 | United States |
| Forest Investigative Site 100 | Houston | Texas | 77034 | United States |
| Forest Investigative Site 067 | Katy | Texas | 77450 | United States |
| Forest Investigative Site 049 | Pasadena | Texas | 77505 | United States |
| Forest Investigative Site 030 | San Antonio | Texas | 78209 | United States |
| Forest Investigative Site 076 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site 065 | Sugarland | Texas | 77479 | United States |
| Forest Investigative Site 019 | Ogden | Utah | 84405 | United States |
| Forest Investigative Site 105 | Salt Lake City | Utah | 84107 | United States |
| Forest Investigative Site 113 | Sandy City | Utah | 84094 | United States |
| Forest Investigative Site 053 | Charlottesville | Virginia | 22911 | United States |
| Forest Investigative Site 108 | Chesapeake | Virginia | 23320 | United States |
| Forest Investigative Site 136 | Chesapeake | Virginia | 23320 | United States |
| Forest Investigative Site 148 | Christiansburg | Virginia | 24073 | United States |
| Forest Investigative Site 072 | Lynchburg | Virginia | 24502 | United States |
| Forest Investigative Site 069 | Newport News | Virginia | 23606 | United States |
| Forest Investigative Site 013 | Norfolk | Virginia | 23502 | United States |
| Forest Investigative Site 038 | Richmond | Virginia | 23294 | United States |
| Forest Investigative Site 103 | Spokane | Washington | 99208 | United States |
| Forest Investigative Site 082 | La Crosse | Wisconsin | 54601 | United States |
| Forest Investigative Site 096 | Milwaukee | Wisconsin | 53215 | United States |
| Forest Investigative Site 054 | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| Forest Investigative Site 059 | Sarnia | Ontario | N7T 4X3 | Canada |
| Forest Investigative Site 086 | Toronto | Ontario | M4S 1Y2 | Canada |
| Forest Investigative Site 147 | Toronto | Ontario | M9W 4L6 | Canada |
| Forest Investigative Site 152 | Vaughan | Ontario | L4L 4Y7 | Canada |
| FG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| COMPLETED |
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| NOT COMPLETED |
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A total of 487 patients were randomized to treatment (Randomized Population). The Safety population consists of the 486 randomized who received at least one dose of study drug. The Demographic and Baseline Characteristics data reported here is for the Safety Population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| BG001 | Linaclotide 145 Micrograms | Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| BG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Weight, mean | Mean | Standard Deviation | kg |
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| Height, mean | Mean | Standard Deviation | cm |
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| BMI (Body Mass Index), mean | Mean | Standard Deviation | kilograms per meter squared |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Secondary | 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder | A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Number | participants | 12-week treatment period |
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| Secondary | Change From Baseline in 12-Week Abdominal Bloating | Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-week treatment period |
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| Secondary | Percent Change From Baseline in 12-week Abdominal Bloating | Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | percentage change of NRS score | Baseline and 12-week treatment period |
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| Secondary | Percent Change From Baseline in Abdominal Bloating at Week 12 | Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12. | Reported outcome data is based on the 483 patient Intent-to-Treat Population. The distribution of each of the linaclotide groups was compared, in a pair-wise manner, to the placebo group using the two-sample Kolmogorov-Smirnov test. | Posted | Mean | Standard Deviation | percentage change in abdominal bloating | Baseline and Week 12 |
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| Secondary | 6/12 Week Abdominal Bloating 30% Responder | A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient's improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Number | participants | 12-week treatment period |
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| Secondary | Change From Baseline in 12-week CSBM Frequency Rate | A patient's 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | CSBMs per week | Baseline and 12-week treatment period |
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| Secondary | Change From Baseline in CSBM Frequency Rate at Week 1. | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | CSBMs per week | Baseline and Week 1 |
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| Secondary | Change From Baseline in CSBM Frequency Rate at Week 4. | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | CSBMs per week | Baseline and Week 4 |
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| Secondary | Change From Baseline in CSBM Frequency Rate at Week 8 | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | CSBMs per week | Baseline and Week 8 |
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| Secondary | Change From Baseline in CSBM Frequency Rate at Week 12 | A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | CSBMs per week | Baseline and Week 12 |
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| Secondary | Change From Baseline in 12-Week SBM Frequency Rate | A patient's Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | SBMs per week | 12-week treatment period |
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| Secondary | Change From Baseline in SBM Frequency Rate at Week 1 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | SBMs per week | Baseline and Week 1 |
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| Secondary | Change From Baseline in SBM Frequency Rate at Week 4 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | SBMs per week | Baseline and Week 4 |
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| Secondary | Change From Baseline in SBM Frequency Rate at Week 8 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | SBMs per week | Baseline and Week 8 |
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| Secondary | Change From Baseline in SBM Frequency Rate at Week 12 | A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | SBMs per week | Baseline and Week 12 |
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| Secondary | Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM) | A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | Days per week | Baseline and 12-week treatment period |
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| Secondary | SBM Within 24 Hours After the First Dose of Investigational Product | The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Number | participants | 24 hours from first dose of investigational product (Day 1) |
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| Secondary | Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product | Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time). Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Median | 95% Confidence Interval | Hours | 12-week treatment period |
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| Secondary | Change From Baseline in 12-week Stool Consistency | Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):
A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-week treatment period |
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| Secondary | Change From Baseline in Stool Consistency at Week 12 | Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):
A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in 12-week Severity of Straining | Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-week treatment period |
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| Secondary | Change From Baseline in Severity of Straining at Week 12 | Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
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| Secondary | 9/12 Week Mild Straining and Diarrhea-free Responder | A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Number | participants | 12-week treatment period |
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| Primary | 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder | A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline. | 487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population | Posted | Number | participants | 12-week treatment period |
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Adverse event reporting occurred over a 10 month period from August of 2012 to June of 2013 at 141 study sites in the United States and Canada
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast | 2 | 173 | 12 | 173 | ||
| EG001 | Linaclotide 145 Micrograms | Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast | 4 | 153 | 25 | 153 | ||
| EG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast | 2 | 160 | 33 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| brain stem infarction | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
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| non-cardiac chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
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| gastroenteritis viral | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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All data generated in this trial will be the property of Forest Research Institute, Inc. and Ironwood Pharmaceuticals, Inc. An integrated clinical and statistical report will be prepared at the completion of the trial.
Publication of the results by the Investigator will be subject to mutual agreement between the Investigator, Ironwood Pharmaceuticals, Inc., and Forest Research Institute, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Shiff, Executive Director, Clinical Development | Forest Research Institute | 201-427-8000 | 8077 | Steven.Shiff@actavis.com |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Age 40 to 64 years |
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| Age ≥ 65 years |
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| Female |
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| Black or African American |
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| American Indian or Alaska Native |
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| Asian |
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| Other |
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| Non-Hispanic |
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| Canada |
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Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
|
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 |
| Linaclotide 290 Micrograms |
Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
|
| OG001 |
| Linaclotide 145 Micrograms |
Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| Linaclotide 145 Micrograms |
Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
Linaclotide 145 micrograms Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
| OG002 | Linaclotide 290 Micrograms | Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast |
|
|
|
|
|