Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 72 ug linaclotide acetate | Active Comparator |
| |
| 145 ug linaclotide acetate | Active Comparator |
| |
| 290 ug linaclotide acetate | Active Comparator |
| |
| 579 ug linaclotide acetate | Active Comparator |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linaclotide acetate | Drug | oral, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency | Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period. | Change from Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| SBM 75% Responder for the Treatment Period (Based on the Normalized Rate) | A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Microbia Medical Affairs | Microbia, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microbia Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Microbia Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20045700 | Derived | Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4. |
Not provided
Not provided
Patients went through a 14 to 17 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS).
Patient recruitment occurred over a 13 month period from November 2006 to December 2007 at 57 US study sites.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Linaclotide, 72μg | Linaclotide, 72μg dose, oral administration, once per day |
| FG001 | Linaclotide, 145μg | Linaclotide, 145μg dose, oral administration, once per day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Matching placebo | Drug | oral, once daily |
|
| Change from Baseline to Week 4 |
| CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate) | A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate. | Change from Baseline to Week 4 |
| Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period | CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call? | Change from Baseline to Week 4 |
| Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period | Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid. | Change from Baseline to Week 4 |
| Change From Baseline in Straining Score for the Treatment Period | Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount. | Change from Baseline to Week 4 |
| Tucson |
| Arizona |
| 85715 |
| United States |
| Microbia Investigational Site | Sherwood | Arkansas | 72120 | United States |
| Microbia Investigational Site | Anaheim | California | United States |
| Microbia Investigational Site | Sacramento | California | United States |
| Microbia Investigational Site | San Diego | California | United States |
| Microbia Investigational Site | Boulder | Colorado | United States |
| Microbia Investigational Site | Bristol | Connecticut | 06011 | United States |
| Microbia Investigational Site | Boynton Beach | Florida | United States |
| Microbia Investigational Site | Port Orange | Florida | United States |
| Microbia Investigational Site | Tampa | Florida | United States |
| Microbia Investigational Site | Stockbridge | Georgia | 30281 | United States |
| Microbia Investigational Site | Peoria | Illinois | 61602 | United States |
| Microbia Investigational Site | Indianapolis | Indiana | 46237 | United States |
| Microbia Investigational Site | Clive | Iowa | United States |
| Microbia Investigational Site | Davenport | Iowa | United States |
| Microbia Investigational Site | Louisville | Kentucky | United States |
| Microbia Investigational Site | Monroe | Louisiana | 71201 | United States |
| Microbia Investigational Site | Silver Spring | Maryland | 20901 | United States |
| Microbia Investigational Site | Boston | Massachusetts | United States |
| Microbia Investigational Site | Ann Arbor | Michigan | United States |
| Microbia Investigational Site | Traverse City | Michigan | 49684 | United States |
| Microbia Investigational Site | Olive Branch | Mississippi | United States |
| Microbia Investigational Site | Lincoln | Nebraska | United States |
| Microbia Investigational Site | Great Neck | New York | United States |
| Microbia Investigational Site | Pittsford | New York | United States |
| Microbia Investigational Site | Asheville | North Carolina | 28801 | United States |
| Microbia Investigational Site | Chapel Hill | North Carolina | 9199668328 | United States |
| Microbia Investigational Site | Charlotte | North Carolina | 28075 | United States |
| Microbia Investigational Site | Fayetteville | North Carolina | United States |
| Microbia Investigational Site | Greensboro | North Carolina | United States |
| Microbia Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Microbia Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Microbia Investigational Site | Cincinnati | Ohio | United States |
| Microbia Investigational Site | Dayton | Ohio | 45440 | United States |
| Microbia Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Microbia Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Microbia Investigational Site | Oklahoma City | Oklahoma | 73116 | United States |
| Microbia Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Microbia Investigational Site | Pittsburgh | Pennsylvania | United States |
| Microbia Investigational Site | Sellersville | Pennsylvania | United States |
| Microbia Investigational Site | Anderson | South Carolina | United States |
| Microbia Investigational Site | Columbia | South Carolina | United States |
| Microbia Investigational Site | Simpsonville | South Carolina | United States |
| Microbia Investigational Site | Summerville | South Carolina | 29485 | United States |
| Microbia Investigational Site | Bristol | Tennessee | United States |
| Microbia Investigational Site | Chattanooga | Tennessee | United States |
| Microbia Investigational Site | Germantown | Tennessee | United States |
| Microbia Investigational Site | Jackson | Tennessee | 38301 | United States |
| Microbia Investigational Site | Austin | Texas | 78745 | United States |
| Microbia Investigational Site | Corsicana | Texas | 75110 | United States |
| Microbia Investigational Site | El Paso | Texas | United States |
| Microbia Investigational Site | San Antonio | Texas | United States |
| Microbia Investigational Site | Ogden | Utah | United States |
| Microbia Investigational Site | Chesapeake | Virginia | 23320 | United States |
| Microbia Investigational Site | Lynchburg | Virginia | 24502 | United States |
| Microbia Investigational Site | Olympia | Washington | United States |
| Microbia Investigational Site | Spokane | Washington | United States |
| Microbia Investigational Site | La Crosse | Wisconsin | 54601 | United States |
| Microbia Investigational Site | Madison | Wisconsin | United States |
| FG002 | Linaclotide, 290μg | Linaclotide, 290μg dose, oral administration, once per day |
| FG003 | Linaclotide, 579μg | Linaclotide, 579μg dose, oral administration, once per day |
| FG004 | Placebo | Dose-matched placebo, oral administration, once per day. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Linaclotide, 72μg | Linaclotide, 72μg dose, oral administration, once per day |
| BG001 | Linaclotide, 145μg | Linaclotide, 145μg dose, oral administration, once per day. One patient was randomized into the study but did not receive ≥ 1 dose of study drug, thus was not included in the Safety Population. |
| BG002 | Linaclotide, 290μg | Linaclotide, 290μg dose, oral administration, once per day |
| BG003 | Linaclotide, 579μg | Linaclotide, 579μg dose, oral administration, once per day |
| BG004 | Placebo | Dose-matched placebo, oral administration, once per day. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency | Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period. | 307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 "How many bowel movements did you have today or yesterday since your last call?" were included in the intent-to-treat (ITT) Population. | Posted | Least Squares Mean | Standard Error | SBMs per week | Change from Baseline to Week 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SBM 75% Responder for the Treatment Period (Based on the Normalized Rate) | A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate. | 307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 "How many bowel movements did you have today or yesterday since your last call?" were included in the ITT Population. | Posted | Number | participants | Change from Baseline to Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate) | A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate. | 307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 "How many bowel movements did you have today or yesterday since your last call?" were included in the ITT Population. | Posted | Number | participants | Change from Baseline to Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period | CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call? | 307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 "How many bowel movements did you have today or yesterday since your last call?" were included in the ITT Population. | Posted | Least Squares Mean | Standard Error | CSBMs per week | Change from Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period | Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid. | 307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 "How many bowel movements did you have today or yesterday since your last call?" were included in the ITT. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Change from Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Straining Score for the Treatment Period | Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount. | 307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 "How many bowel movements did you have today or yesterday since your last call?" were included in the ITT Population. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Change from Baseline to Week 4 |
|
Adverse event data were collected from November of 2006 to February of 2008.
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 | Linaclotide, 72μg | Linaclotide, 72μg dose, oral administration, once per day | 0 | 59 | 7 | 59 | ||
| EG001 | Linaclotide, 145μg | Linaclotide, 145μg dose, oral administration, once per day | 0 | 56 | 11 | 56 | ||
| EG002 | Linaclotide, 290μg | Linaclotide, 290μg dose, oral administration, once per day | 0 | 62 | 5 | 62 | ||
| EG003 | Linaclotide, 579μg | Linaclotide, 579μg dose, oral administration, once per day | 0 | 63 | 11 | 63 | ||
| EG004 | Placebo | Dose-matched placebo, oral administration, once per day. | 2 | 69 | 7 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Humerus fracture | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
The disclosure restriction on the PI is that publication cannot be made for 24 months from the date of final data lock of the study, the sponsor can review the publication prior to public release, sponsor requires a minimum 60 day review period for each publication, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request an additional delay period of 60 days in order to protect potentially patentable information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Levine, MD | Ironwood Pharmaceuticals | 617.374.3906 | dlevine@ironwoodpharma.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
| ID | Term |
|---|---|
| C523483 | linaclotide |
Not provided
Not provided
Not provided
| Older than 65 years |
|
| Male |
|
| ANCOVA |
| 0.0010 |
| 95 |
| No |
| Superiority or Other |
| The null hypothesis is that the active treatment group is equal to the placebo group. | ANCOVA | <0.0001 | 95 | No | Superiority or Other |
| The null hypothesis is that the active treatment group is equal to the placebo group. | ANCOVA | <0.0001 | 95 | No | Superiority or Other |
| Linaclotide, 579μg |
Linaclotide, 579μg dose, oral administration, once per day |
| OG004 | Placebo | Dose-matched placebo, oral administration, once per day. |
|
|
| OG003 |
| Linaclotide, 579μg |
Linaclotide, 579μg dose, oral administration, once per day |
| OG004 | Placebo | Dose-matched placebo, oral administration, once per day. |
|
|
| OG004 | Placebo | Dose-matched placebo, oral administration, once per day. |
|
|
| OG003 | Linaclotide, 579μg | Linaclotide, 579μg dose, oral administration, once per day |
| OG004 | Placebo | Dose-matched placebo, oral administration, once per day. |
|
|
Linaclotide, 579μg dose, oral administration, once per day
| OG004 | Placebo | Dose-matched placebo, oral administration, once per day. |
|
|