ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
CompletedPhase 2NCT01100151
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
Study details
- Official title
- A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain
- Conditions
- Opioid-induced Constipation
- Interventions
- Drug: RDC-1036 (ALKS 37)
- Drug: Placebo
- Sponsor
- Alkermes, Inc.
- Start date
- 2010-04
- Primary completion
- 2010-12
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 11
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 18 to 70 years of age * Body mass index (BMI) of 19 to 35 kg/m2 at screening * Receiving prescribed opioid medication for the management of chronic, non-cancer, pain * Diagnosis of opioid-induced constipation (OIC) * Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during the study. Exclusion Criteria: * Pregnancy and/or currently breastfeeding * Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed) * Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction * Any gastrointestinal (GI) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars) * Use of medical devices such as pacemakers, infusion pumps, or insulin pumps * Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study * Participation in a clinical trial of a pharmacological agent within 30 days before screening
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01100151