Opioid-induced Constipation
Conditions
Keywords
Opioid-induced constipation, RDC-1036, ALKS 37
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.
Interventions
DRUGRDC-1036 (ALKS 37)
Capsules for oral administration
DRUGPlacebo
Capsules for oral administration
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period | 4 Weeks | — |
| Number of subjects reporting treatment-emergent adverse events (TEAEs) | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed