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This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.
Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.
Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.
The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.0 mg plecanatide | Active Comparator | Plecanatide 3.0 mg dosed daily for 12 weeks |
|
| 6.0 mg plecanatide | Active Comparator | Plecanatide 6.0 mg dosed daily for 12 weeks |
|
| Matching placebo | Active Comparator | Placebo dosed daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plecanatide | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Overall Responders - ITT Population | An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks. | 12 weeks |
| Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks | An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | 12 Weeks |
| Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks | A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sustained Efficacy Responders | A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period. | 12 Weeks |
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Inclusion Criteria:
• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul F.C. Eng, PhD | Synergy Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Research Site | Birmingham | Alabama | 35209 | United States | ||
| Synergy Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41214272 | Derived | Brenner DM, Shin AS, Laitman AP, Deutsch JK, Kunkel DC. The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint. J Gastroenterol Hepatol. 2025 Dec;40(12):2890-2897. doi: 10.1111/jgh.70119. Epub 2025 Nov 10. | |
| 37332239 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Matching Placebo | Placebo Tablets dosed once daily for 12 weeks |
| FG001 | 3.0 mg Plecanatide | Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Change From Baseline in Stool Consistency | Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:
| Baseline and 12-Week |
| Change From Baseline in Straining | Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining). | Baseline and 12-Week |
| Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement | Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | Baseline and 12-Week |
| Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication | A responder was any patient with a SBM within 24 hours after the first dose of study drug. | Up to 24 hours after the first dose of study drug |
| Change From Baseline in Abdominal Pain | Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week. | Baseline and 12-Week |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Synergy Research Site | Guntersville | Alabama | 35976 | United States |
| Synergy Research Site | Huntsville | Alabama | 35801 | United States |
| Synergy Research Site | Saraland | Alabama | 36571 | United States |
| Synergy Research Site | Glendale | Arizona | 85301 | United States |
| Synergy Research Site | Phoenix | Arizona | 85018 | United States |
| Synergy Research Site | Surprise | Arizona | 85374 | United States |
| Synergy Research Site | Tucson | Arizona | 85745 | United States |
| Synergy Research Site | Conway | Arkansas | 72034 | United States |
| Synergy Research Site | Little Rock | Arkansas | 72205 | United States |
| Synergy Research Site | Canoga Park | California | 91303 | United States |
| Synergy Research Site | Carmichael | California | 95608 | United States |
| Synergy Research Site | Chino | California | 91710 | United States |
| Synergy Research Site | Chula Vista | California | 91910 | United States |
| Synergy Research Site | El Cajon | California | 92020 | United States |
| Synergy Research Site | Encino | California | 91436 | United States |
| Synergy Research Site | Foothill Ranch | California | 92610 | United States |
| Synergy Research Site | Garden Grove | California | 92844 | United States |
| Synergy Research Site | Huntington Beach | California | 92647 | United States |
| Synergy Research Site | Irvine | California | 92614 | United States |
| Synergy Research Site | Lomita | California | 90717 | United States |
| Synergy Research Site | Long Beach | California | 90806 | United States |
| Synergy Research Site | Los Angeles | California | 90045 | United States |
| Synergy Research Site | Mission Hills | California | 91345 | United States |
| Synergy Research Site | Montclair | California | 91763 | United States |
| Synergy Research Site | Northridge | California | 91324 | United States |
| Synergy Research Site | Norwalk | California | 90650 | United States |
| Synergy Research Site | Oceanside | California | 92056 | United States |
| Synergy Research Site | Orange | California | 92868 | United States |
| Synergy Research Site | Orangevale | California | 95662 | United States |
| Synergy Research Site | Placentia | California | 92870 | United States |
| Synergy Research Site | Riverside | California | 92501 | United States |
| Synergy Research Site | San Diego | California | 92103 | United States |
| Synergy Research Site | San Marino | California | 91108 | United States |
| Synergy Research Site | Santa Ana | California | United States |
| Synergy Research Site | Sherman Oaks | California | 91403 | United States |
| Synergy Research Site | Colorado Springs | Colorado | 80920 | United States |
| Synergy Research Site | Denver | Colorado | 80246 | United States |
| Synergy Research Site | Hamden | Connecticut | 06517 | United States |
| Synergy Research Site | Atlantis | Florida | 33462 | United States |
| Synergy Research Site | Boca Raton | Florida | 33428 | United States |
| Synergy Research Site | Bradenton | Florida | 34201 | United States |
| Synergy Research Site | Brandon | Florida | 33511 | United States |
| Synergy Research Site | Brooksville | Florida | 34601 | United States |
| Synergy Research Site | Clearwater | Florida | 33756 | United States |
| Synergy Research Site | Cutler Bay | Florida | 33189 | United States |
| Synergy Research Site | Fort Lauderdale | Florida | 33306 | United States |
| Synergy Research Site | Fort Lauderdale | Florida | 33312 | United States |
| Synergy Research Site | Hialeah | Florida | 33012 | United States |
| Synergy Research Site | Hialeah | Florida | 33013 | United States |
| Synergy Research Site | Hialeah | Florida | 33016 | United States |
| Synergy Research Site. | Jacksonville | Florida | 32256 | United States |
| Synergy Research Site | Lauderdale Lakes | Florida | 33319 | United States |
| Synergy Research Site | Maitland | Florida | 32751 | United States |
| Synergy Research Site | Miami | Florida | 33015 | United States |
| Synergy Research Site | Miami | Florida | 33016 | United States |
| Synergy Research Site | Miami | Florida | 33032 | United States |
| Synergy Research Site | Miami | Florida | 33122 | United States |
| Synergy Research Site | Miami | Florida | 33126 | United States |
| Synergy Research Site | Miami | Florida | 33136 | United States |
| Synergy Research Site | Miami | Florida | 33144 | United States |
| Synergy Research Site | Miami | Florida | 33155 | United States |
| Synergy Research Site | Miami | Florida | 33165 | United States |
| Synergy Research Site | Miami | Florida | 33173 | United States |
| Synergy Research Site | Miami | Florida | 33176 | United States |
| Synergy Research Site | Miami | Florida | 33183 | United States |
| Synergy Research Site | Miami Lakes | Florida | 33016 | United States |
| Synergy Research Site | Miami Lakes | Florida | 33173 | United States |
| Synergy Research Site | Miami Springs | Florida | 33166 | United States |
| Synergy Research Site | Naples | Florida | 34102 | United States |
| Synergy Research Site | North Miami Beach | Florida | 33162 | United States |
| Synergy Research Site | Orange Park | Florida | 32073 | United States |
| Synergy Research Site. | Orlando | Florida | 32806 | United States |
| Synergy Research Site | Orlando | Florida | 32807 | United States |
| Synergy Research Site | Ormond Beach | Florida | 32174 | United States |
| Synergy Research Site | Pembroke Pines | Florida | 33024 | United States |
| Synergy Research Site | Pinellas Park | Florida | 33782 | United States |
| Synergy Research Site | Port Orange | Florida | 32127 | United States |
| Synergy Research Site | Tamarac | Florida | 33319 | United States |
| Synergy Research Site | Tampa | Florida | 33613 | United States |
| Synergy Research Site | Tampa | Florida | 33634 | United States |
| Synergy Research Site | Williston | Florida | 32696 | United States |
| Synergy Research Site | Atlanta | Georgia | 30322 | United States |
| Synergy Research Site | Atlanta | Georgia | 30342 | United States |
| Synergy Research Site | Decatur | Georgia | 30033 | United States |
| Synergy Research Site | Lilburn | Georgia | 30047 | United States |
| Synergy Research Site | Marietta | Georgia | 30060 | United States |
| Synergy Research Site | Snellville | Georgia | 30078 | United States |
| Synergy Research Site | Blackfoot | Idaho | 83221 | United States |
| Synergy Research Site | Boise | Idaho | 83709 | United States |
| Synergy Research Site | Meridian | Idaho | 83646 | United States |
| Synergy Research Site | Blue Island | Illinois | 60406 | United States |
| Synergy Research Site | Chicago | Illinois | 60602 | United States |
| Synergy Research Site | Evanston | Illinois | 60201 | United States |
| Synergy Research Site | Hoffman Estates | Illinois | 60169 | United States |
| Synergy Research Site | Morton | Illinois | 61550 | United States |
| Synergy Research Site | Oak Lawn | Illinois | 60453 | United States |
| Synergy Research Site | Schaumburg | Illinois | 60194 | United States |
| Synergy Research Site | Brownsburg | Indiana | 46112 | United States |
| Synergy Research Site | Indianapolis | Indiana | 46237 | United States |
| Synergy Research Site | Wichita | Kansas | 67203 | United States |
| Synergy Research Site | Madisonville | Kentucky | 42431 | United States |
| Synergy Research Site | Owensboro | Kentucky | 42303 | United States |
| Synergy Research Site | Marrero | Louisiana | 70072 | United States |
| Synergy Research Site | Annapolis | Maryland | 21401 | United States |
| Synergy Research Site | Catonsville | Maryland | 21228 | United States |
| Synergy Research Site | Oxon Hill | Maryland | 20745 | United States |
| Synergy Research Site | Towson | Maryland | 21204 | United States |
| Synergy Research Site | Marlborough | Massachusetts | 01752 | United States |
| Synergy Research Site | Quincy | Massachusetts | 02169 | United States |
| Synergy Research Site | Kalamazoo | Michigan | 49009 | United States |
| Synergy Research Site | Port Gibson | Mississippi | 39150 | United States |
| Synergy Research Site | Chesterfield | Missouri | 63005 | United States |
| Synergy Research Site | St Louis | Missouri | 63128 | United States |
| Synergy Research Site | St Louis | Missouri | 63141 | United States |
| Synergy Research Site | Missoula | Montana | 59808 | United States |
| Synergy Research Site | Omaha | Nebraska | 68114 | United States |
| Synergy Research Site | Las Vegas | Nevada | 89119 | United States |
| Synergy Research Site | Blackwood | New Jersey | 08012 | United States |
| Synergy Research Site | Egg Harbor | New Jersey | 08234 | United States |
| Synergy Research Site | Vineland | New Jersey | 08360 | United States |
| Synergy Research Site | Albuquerque | New Mexico | 87109 | United States |
| Synergy Research Site | Hopewell Junction | New York | 12533 | United States |
| Synergy Research Site | Kew Gardens | New York | 11415 | United States |
| Synergy Research Site | New York | New York | 10016 | United States |
| Synergy Research Site | Poughkeepsie | New York | 12601 | United States |
| Synergy Research Site | Chapel Hill | North Carolina | 27514 | United States |
| Synergy Research Site | Fayetteville | North Carolina | 28304 | United States |
| Synergy Research Site | High Point | North Carolina | 27262 | United States |
| Synergy Research Site | Jacksonville | North Carolina | 28546 | United States |
| Synergy Research Site | Raleigh | North Carolina | 27609 | United States |
| Synergy Research Site | Salisbury | North Carolina | 28144 | United States |
| Synergy Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Synergy Research Site | Cincinnati | Ohio | 45224 | United States |
| Synergy Research Site | Cincinnati | Ohio | 45242 | United States |
| Synergy Research Site | Cincinnati | Ohio | 45249 | United States |
| Synergy Research Site | Columbus | Ohio | 43214 | United States |
| Synergy Research Site | Dayton | Ohio | 45419 | United States |
| Synergy Research Site | Dayton | Ohio | 45439 | United States |
| Synergy Research Site | Franklin | Ohio | 45005 | United States |
| Synergy Research Site | Kettering | Ohio | 45429 | United States |
| Synergy Research Site | Mentor | Ohio | 44060 | United States |
| Synergy Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Synergy Research Site | Wadsworth | Ohio | 44203 | United States |
| Synergy Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Synergy Research Site | Doylestown | Pennsylvania | 18901 | United States |
| Synergy Research Site | Lansdale | Pennsylvania | 19446 | United States |
| Synergy Research Site | Levittown | Pennsylvania | 19056 | United States |
| Synergy Research Site | Philadelphia | Pennsylvania | 19140 | United States |
| Synergy Research Site | Anderson | South Carolina | 29621 | United States |
| Synergy Research Site | Greer | South Carolina | 29651 | United States |
| Synergy Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Synergy Research Site | Fayetteville | Tennessee | 37334 | United States |
| Synergy Research Site | Franklin | Tennessee | 37067 | United States |
| Synergy Research Site | Hermitage | Tennessee | 37076 | United States |
| Synergy Research Site | Jackson | Tennessee | 38305 | United States |
| Synergy Research Site | Kingsport | Tennessee | 37660 | United States |
| Synergy Research Site | Knoxville | Tennessee | 37909 | United States |
| Synergy Research Site | Austin | Texas | 78731 | United States |
| Synergy Research Site | Austin | Texas | 78758 | United States |
| Synergy Research Site | Baytown | Texas | 77521 | United States |
| Synergy Research Site | Beaumont | Texas | 77701 | United States |
| Synergy Research Site | Channelview | Texas | 77530 | United States |
| Synergy Research Site | Dallas | Texas | 75224 | United States |
| Synergy Research Site | Dallas | Texas | 75231 | United States |
| Synergy Research Site | Dallas | Texas | 75254 | United States |
| Synergy Research Site | Houston | Texas | 77008 | United States |
| Synergy Research Site | Houston | Texas | 77081 | United States |
| Synergy Research Site | Humble | Texas | 77338 | United States |
| Synergy Research Site | Lampasas | Texas | 76550 | United States |
| Synergy Research Site | McKinney | Texas | 75070 | United States |
| Synergy Research Site | Missouri City | Texas | 77459 | United States |
| Synergy Research Site | Plano | Texas | 75024 | United States |
| Synergy Research Site | Plano | Texas | 75075 | United States |
| Synergy Research Site | Port Arthur | Texas | 77640 | United States |
| Synergy Research Site | San Antonio | Texas | 78209 | United States |
| Synergy Research Site | San Antonio | Texas | 78215 | United States |
| Synergy Research Site | San Antonio | Texas | 78229 | United States |
| Synergy Research Site | Sugar Land | Texas | 77478 | United States |
| Synergy Research Site | Orem | Utah | 84058 | United States |
| Synergy Research Site | West Valley City | Utah | 84120 | United States |
| Synergy Research Site | Chesapeake | Virginia | 23320 | United States |
| Synergy Research Site | Fairfax | Virginia | 22031 | United States |
| Synergy Research Site | Norfolk | Virginia | 23507 | United States |
| Synergy Research Site | Richmond | Virginia | 23220 | United States |
| Synergy Research Site | Richmond | Virginia | 23235 | United States |
| Synergy Research Site | Spokane | Washington | 99202 | United States |
| Synergy Research Site | Vancouver | Washington | 98664 | United States |
| Synergy Research Site | Kingwood | West Virginia | 26537 | United States |
| Synergy Research Site | La Crosse | Wisconsin | 54601 | United States |
| Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18. |
| 32660770 | Derived | Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10. |
| FG002 | 6.0 mg Plecanatide | Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Matching Placebo | Placebo Tablets dosed once daily for 12 weeks |
| BG001 | 3.0 mg Plecanatide | Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks |
| BG002 | 6.0 mg Plecanatide | Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks |
| BG003 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Overall Responders - ITT Population | An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks. | Posted | Count of Participants | Participants | 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks | An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | Posted | Count of Participants | Participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks | A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | Posted | Count of Participants | Participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Sustained Efficacy Responders | A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period. | Posted | Count of Participants | Participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Stool Consistency | Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:
| Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-Week |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Straining | Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-Week |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement | Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | Posted | Mean | Standard Deviation | CSBMs per week | Baseline and 12-Week |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication | A responder was any patient with a SBM within 24 hours after the first dose of study drug. | Posted | Count of Participants | Participants | Up to 24 hours after the first dose of study drug |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Abdominal Pain | Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-Week |
|
|
Not provided
The safety population consisted of 1130 patients who had received at least one dose of the study drug. A total of 1135 patients were randomized and five randomized patients did not receive study drug after being randomized in the study.
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 | Matching Placebo | Placebo Tablets dosed once daily for 12 weeks | 1 | 376 | 13 | 376 | ||
| EG001 | 3.0 mg Plecanatide | Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks | 2 | 375 | 21 | 375 | ||
| EG002 | 6.0 mg Plecanatide | Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks | 3 | 379 | 22 | 379 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA version 14.1 | Systematic Assessment |
| |
| LFT abnormal | Investigations | MedDRA version 14.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Regulatory Affairs & Clinical QA | Synergy Pharmaceuticals Inc. | 646-675-7283 | ejaeger@synergypharma.com |
| ID | Term |
|---|---|
| C584575 | plecanatide |
Not provided
Not provided
Not provided
| Male |
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