A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
Study Overview
Brief Summary
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
Detailed Description
Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RDC-1036 (ALKS 37)
Capsules for oral administration
Intervention: RDC-1036 (ALKS 37) (Drug)
Placebo
Capsules for oral administration
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
Time Frame: 4 Weeks
Number of subjects reporting treatment-emergent adverse events (TEAEs)
Time Frame: 6 Weeks
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Secondary Outcomes
- Change in rescue laxative use from pre-treatment to treatment period(4 Weeks)
- Study drug dose prior to first SBM after randomization(4 weeks)
- Scores to study-related questionnaires(6 weeks)