Study Evaluating Oral MOA-728 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:
NCT00547586
First received: October 19, 2007
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 with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).


Condition Intervention Phase
Constipation
Drug: N-methylnaltrexone bromide (MOA-728)
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Other: placebo
placebo
Experimental: 2 Drug: N-methylnaltrexone bromide (MOA-728)
Oral
Experimental: 3 Drug: N-methylnaltrexone bromide (MOA-728)
Oral
Experimental: 4 Drug: N-methylnaltrexone bromide (MOA-728)
Oral
Experimental: 5 Drug: N-methylnaltrexone bromide (MOA-728)
Oral

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547586

  Show 41 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00547586     History of Changes
Other Study ID Numbers: 3200A3-2201
Study First Received: October 19, 2007
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
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014