ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

July 31, 2012 updated by: Alkermes, Inc.

A Phase 2b Randomized, Double-blind, Placebo-controlled, 12-week Study to Evaluate the Safety and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation

The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92804
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Alkermes Investigational Site
      • Plantation, Florida, United States, 33317
        • Alkermes Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Alkermes Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Alkermes Investigational Site
    • Nevada
      • Los Vegas, Nevada, United States, 89119
        • Alkermes Investigational Site
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • Alkermes Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Alkermes Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77098
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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, Vivitrol, 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

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
Time Frame
Change from baseline in the weekly average of complete spontaneous bowel movements during treatment
Time Frame: Weeks 1 through 4 of treatment
Weeks 1 through 4 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK37-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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