Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

This study has been completed.
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00605644
First received: January 18, 2008
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).


Condition Intervention Phase
Constipation
Drug: MOA-728
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Spontaneous Bowel Movements [ Time Frame: App. 1 month ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo
Experimental: 2
MOA-728
Drug: MOA-728
Oral Capsules
Experimental: 3
MOA-728
Drug: MOA-728
Oral Capsules
Experimental: 4
MOA-728
Drug: MOA-728
Oral Capsules
Experimental: 5
MOA-728
Drug: MOA-728
Oral Capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
  • Taking oral, transdermal, intravenous, or subcutaneous opioids.
  • Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

  • History of chronic constipation before the initiation of opioid therapy.
  • Other GI disorders known to affect bowel transit.
  • Women who are pregnant, breast feeding, or plan to become pregnant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605644

Sponsors and Collaborators
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Jeff Cohn Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00605644     History of Changes
Other Study ID Numbers: 3200A3-2202
Study First Received: January 18, 2008
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014