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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01983306 | Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) | PHASE2 | COMPLETED | 292 | — | — | Nov 1, 2013 | Apr 1, 2015 | May 7, 2021 | 42 | United States |
Compare SP-333 (1, 3 \& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
| Arm | Type | Description |
|---|---|---|
| SP-333 1 mg | EXPERIMENTAL | 1 mg SP-333 orally once daily for 4-week Treatment Period |
| SP-333 3 mg | EXPERIMENTAL | 3 mg SP-333 orally once daily for 4-week Treatment Period |
| SP-333 6 mg | EXPERIMENTAL | 6 mg SP-333 orally once daily for 4-week Treatment Period |
| Placebo | PLACEBO_COMPARATOR | Placebo orally once daily for 4-week Treatment Period |
| Name | Type | Description |
|---|---|---|
| SP-333 1 mg | DRUG | Tablet |
| SP-333 3 mg | DRUG | Tablet |
| SP-333 6 mg | DRUG | Tablet |
| Placebo | DRUG | Tablet |
Inclusion Criteria: * Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening * Must have active OIC at screening * Active OIC must be confirmed during baseline screening bowel habit and symptom diary * Must be on stable diet Exclusion ...