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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01418092
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
OIC Drug: ALKS 37 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in the weekly average of complete spontaneous bowel movements during treatment [ Time Frame: Weeks 1 through 4 of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418092


Locations
United States, California
Alkermes Investigational Site
Anaheim, California, United States, 92804
Alkermes Investigational Site
Orange, California, United States, 92868
United States, Florida
Alkermes Investigational Site
Daytona Beach, Florida, United States, 32117
Alkermes Investigational Site
Plantation, Florida, United States, 33317
United States, Georgia
Alkermes Investigational Site
Marietta, Georgia, United States, 30060
United States, Indiana
Alkermes Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Nevada
Alkermes Investigational Site
Los Vegas, Nevada, United States, 89119
United States, New Jersey
Alkermes Investigational Site
Willingboro, New Jersey, United States, 08046
United States, North Carolina
Alkermes Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Alkermes Investigational Site
Austin, Texas, United States, 78756
Alkermes Investigational Site
Houston, Texas, United States, 77098
United States, Washington
Alkermes Investigational Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Richard Leigh-Pemberton, M.D. Alkermes, Inc.
More Information

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01418092     History of Changes
Other Study ID Numbers: ALK37-007
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms