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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02270983 | Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain | PHASE2 | COMPLETED | 254 | — | — | Oct 31, 2014 | Oct 31, 2015 | Apr 8, 2019 | 77 | United States |
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.
| Arm | Type | Description |
|---|---|---|
| Linaclotide 145 micrograms | EXPERIMENTAL | Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. |
| Linaclotide 290 micrograms | EXPERIMENTAL | Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. |
| Placebo | EXPERIMENTAL | Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. |
| Name | Type | Description |
|---|---|---|
| Linaclotide 145 micrograms | DRUG | - |
| Linaclotide 290 micrograms | DRUG | - |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Patient has chronic non-cancer pain that has been present for a minimum of 3 months * Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks * Patient meets protocol criteria for Opioid-Induced Constip...