Clinical trial · Interventional
Alvimopan For The 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 the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks 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 (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alvimopan | Drug | — | UNRESOLVED |
| Alviompan | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Alvimopan 0.5 mg once daily
- description
- 0.5 mg once daily (QD)
- interventionNames
- Drug: Alvimopan
- type
- EXPERIMENTAL
- label
- Alvimopan 0.5 mg twice daily
- description
- 0.5 mg twice daily (BID)
- interventionNames
- Drug: Alviompan
Primary outcomes (1)
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). * Willing to report daily bowel symptoms. 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. * HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
References
Publications (1)
- RESULTIrving G, Penzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013. PMID 21292168