ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)

Phase 2

Completed

• Conditions: Opioid-induced Constipation
• Interventions: Drug: RDC-1036 (ALKS 37); Drug: Placebo

• Registration Number: NCT01100151
• Lead Sponsor: Alkermes, Inc.

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-08
• Disposition First Submitted: 2011-08-18
• Disposition First Submitted QC: 2011-08-18
• Last Update Submitted: 2011-08-18
• Disposition First Posted: 2011-08-23
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RDC-1036 (ALKS 37)	RDC-1036 (ALKS 37)	Capsules for oral administration
Placebo	Placebo	Capsules for oral administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Alkermes Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

Alkermes Investigative Site; 🇺🇸 New Smyrna Beach, Florida, United States