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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01880424 | A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C) | PHASE3 | COMPLETED | 1,722 | — | — | Jul 1, 2013 | May 1, 2015 | Sep 27, 2016 | 82 | United States, Australia +3 |
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
| Arm | Type | Description |
|---|---|---|
| controlled arm | PLACEBO_COMPARATOR | - |
| treatment arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | matching Placebo Capsules, Oral, once daily |
| Linaclotide | DRUG | Linaclotide 290 ug Capsules, Oral, once daily |
Inclusion Criteria: 1. Patient has signed an Informed Consent Form(ICF). 2. Patient Must not be pregnant or breastfeeding and agree to use birth control 3. Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant lab...