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

A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain

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 Overview

• Status: Completed
• Conditions: Opioid-induced Constipation
• Intervention / Treatment: Drug: Placebo; Drug: RDC-1036 (ALKS 37)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Alkermes Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Alkermes Investigational Site
    • Pasadena, California, United States, 91105
      • Alkermes Investigational Site
    • Walnut Creek, California, United States, 94598
      • Alkermes Investigational Site
  • Florida
    • DeLand, Florida, United States, 32734
      • Alkermes Investigational Site
    • New Smyrna Beach, Florida, United States, 32168
      • Alkermes Investigative Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • Alkermes Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Alkermes Investigational Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Alkermes Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 45432
      • Alkermes Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RDC-1036 (ALKS 37); Capsules for oral administration	Drug: RDC-1036 (ALKS 37); Capsules for oral administration
PLACEBO_COMPARATOR: Placebo; Capsules for oral administration	Drug: Placebo; Capsules for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	6 Weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (ESTIMATE): April 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 18, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Opioid-induced constipation; RDC-1036; ALKS 37
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Constipation; Opioid-Induced Constipation
• Other Study ID Numbers: ALK37-003