Clinical trial · Interventional
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain
NCT01901328CI-TRIAL-00035815terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision due to lack of enrollment.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer pain.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-Induced Constipation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CB-5945 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CB-5945
- description
- 0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period
- interventionNames
- Drug: CB-5945
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo administered orally BID for a 12-week treatment period
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12-weeks
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Key Inclusion Criteria: * Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (METDD) for chronic non-cancer pain * Has constipation that is caused by the chronic use of opioids * Is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from Screening until the last study assessment Key Exclusion Criteria: * Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction * Has evidence of intestinal obstruction * Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening * Has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled) * Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone) * Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
References
Publications (0)
Data not yet available
No reference posted for this study.