Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02493452 | Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C) | PHASE3 | COMPLETED | 1,135 | — | — | Jun 1, 2015 | Feb 1, 2017 | Jun 14, 2019 | 191 | United States |
| NCT02387359 | The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) | PHASE3 | COMPLETED | 1,054 | — | — | Dec 1, 2014 | Feb 1, 2017 | Jun 14, 2019 | 155 | United States |
| NCT01722318 | The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) | PHASE2 | COMPLETED | 428 | — | — | Nov 1, 2012 | Oct 1, 2014 | May 28, 2019 | 99 | United States |
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.
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.
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.
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Plecanatide 0.3mg | ACTIVE_COMPARATOR | Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks |
| Plecanatide 1.0mg | ACTIVE_COMPARATOR | Plecanatide 1.0mg one tablet by mouth daily for 12 weeks |
| Plecanatide 3.0mg | ACTIVE_COMPARATOR | Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks |
| Plecanatide 9.0mg | ACTIVE_COMPARATOR | Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo, one tablet by mouth daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Plecanatide | DRUG | - |
| Placebo | DRUG | - |
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: * Refusal or inability to sign informed consent...