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

October 19, 2007
July 22, 2011
October 2007
February 2008   (final data collection date for primary outcome measure)
The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
The effect of the interventional treatment will be measured by bowel movements.
Complete list of historical versions of study NCT00547586 on ClinicalTrials.gov Archive Site
Not Provided
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Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Constipation
  • Drug: N-methylnaltrexone bromide (MOA-728)
    Oral
  • Other: placebo
    placebo
  • Placebo Comparator: 1
    Intervention: Other: placebo
  • Experimental: 2
    Intervention: Drug: N-methylnaltrexone bromide (MOA-728)
  • Experimental: 3
    Intervention: Drug: N-methylnaltrexone bromide (MOA-728)
  • Experimental: 4
    Intervention: Drug: N-methylnaltrexone bromide (MOA-728)
  • Experimental: 5
    Intervention: Drug: N-methylnaltrexone bromide (MOA-728)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547586
3200A3-2201
Yes
Jeff Cohn, Salix Pharmaceuticals
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP