ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation

The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Alkermes Study Site
    • Phoenix, Arizona, United States, 85053
      • Alkermes Study Site
  • California
    • National City, California, United States, 91950
      • Alkermes Study Site
    • Oceanside, California, United States, 92056
      • Alkermes Study Site
    • Pasadena, California, United States, 91105
      • Alkermes Study Site
  • Colorado
    • Denver, Colorado, United States, 80211
      • Alkermes Study Site
  • Florida
    • De Land, Florida, United States, 32724
      • Alkermes Investigational Site
    • Ormond Beach, Florida, United States, 32174
      • Alkermes Study Site
    • St. Petersburg, Florida, United States, 33709
      • Alkermes Study Site
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Alkermes Study Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • Alkermes Study Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Alkermes Study Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Alkermes Study Site
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Alkermes Study Site
  • New Jersey
    • Belvidere, New Jersey, United States, 07823
      • Alkermes Study Site
  • New York
    • Brooklyn, New York, United States, 11218
      • Alkermes Study Site
  • Ohio
    • Cincinnati, Ohio, United States, 45224
      • Alkermes Study Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Alkermes Study Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Alkermes Study Site
  • Texas
    • San Antonio, Texas, United States, 78228
      • Alkermes Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are at least 18 years of age at time of consent
• Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
• Are receiving prescribed opioid medication for the management of chronic, non-cancer pain
• Meet the criteria of OIC
• Agree to use an acceptable method of contraception for the duration of 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) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
• 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: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Capsules for oral administration	Drug: Placebo; Capsules for oral administration
Experimental: ALKS 37; Capsules for oral administration	Drug: ALKS 37; Capsules for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.	Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.	4 weeks

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Richard Leigh-Pemberton, M.D., Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 13, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• 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: ALK37-005