Clinical trial · Interventional
Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Dysfunction | — | UNRESOLVED | — |
| Constipation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alvimopan | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Alvimopan 0.5 mg Twice Daily (BID)
- description
- 0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
- interventionNames
- Drug: Alvimopan
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo was administered orally BID for 12 months.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- To compare alvimopan with placebo for long-term safety and tolerability
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Consented to participate in this study. * Taking opioid therapy for persistent non-cancer pain. * Has bowel dysfunction mainly due to opioids. * Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms. * Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed). Exclusion criteria: * Pregnant, lactating, or planning to become pregnant. * Not ambulatory. * Participated in another trial with an investigational drug in the past 30 days. * Taking opioids for the management of drug addiction or cancer-related pain. * Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation. * Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction. * Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.
References
Publications (0)
Data not yet available