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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01642914 | Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating | PHASE3 | COMPLETED | 487 | — | — | Aug 1, 2012 | Aug 1, 2013 | Apr 26, 2016 | 151 | United States, Canada |
| NCT00765882 | Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation | PHASE3 | COMPLETED | 633 | — | — | Sep 1, 2008 | Aug 1, 2009 | Jan 30, 2013 | 108 | United States, Canada |
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.
A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
| Arm | Type | Description |
|---|---|---|
| Linaclotide 290 micrograms | EXPERIMENTAL | Linaclotide 290 micrograms |
| Linaclotide 145 Micrograms | EXPERIMENTAL | Linaclotide 145 micrograms |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| 1 | EXPERIMENTAL | Linaclotide 290 micrograms |
| 2 | EXPERIMENTAL | Linaclotide 145 micrograms |
| 3 | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| Linaclotide 290 micrograms | DRUG | oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| 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 |
| Placebo | DRUG | Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study |
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 f...