Clinical trial · Interventional
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn \[This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.
Summary
Brief summary (as posted)
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
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 |
|---|---|---|---|
| methylnaltrexone | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 Active Drug
- description
- Methylnaltrexone
- interventionNames
- Drug: methylnaltrexone
- type
- PLACEBO_COMPARATOR
- label
- Group 2 Non-Active Drug
- description
- Placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
- timeFrame
- 1 Day
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Is a man or woman aged 18 years or older. * Has a body weight \>= 38 kg. * Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer). * Has a life expectancy of \>= 6 months. * Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale. * Is taking opioids for cancer-related pain, and not just as-needed doses. * Has a diagnosis of OIC as determined by the investigator. * Is willing to follow the protocol instructions on laxative use during the study. Exclusion Criteria: * Has a history of chronic constipation before starting opioids. * Has renal disease receiving dialysis. * Has an ostomy for stools. * Is a pregnant or breastfeeding woman.
References
Publications (0)
Data not yet available