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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
History of Changes

January 18, 2008
July 22, 2011
January 2008
May 2008   (final data collection date for primary outcome measure)
Spontaneous Bowel Movements [ Time Frame: App. 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00605644 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Evaluating MOA-728 Oral 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 administered MOA-728 who have chronic pain that is not due to 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, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Constipation
  • Drug: MOA-728
    Oral Capsules
  • Drug: Placebo
    Placebo
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    MOA-728
    Intervention: Drug: MOA-728
  • Experimental: 3
    MOA-728
    Intervention: Drug: MOA-728
  • Experimental: 4
    MOA-728
    Intervention: Drug: MOA-728
  • Experimental: 5
    MOA-728
    Intervention: Drug: 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
May 2008
May 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
Not Provided
 
NCT00605644
3200A3-2202
No
Jeff Cohn, Salix Pharmaceuticals
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Study Director: Jeff Cohn Salix Pharmaceuticals
Salix Pharmaceuticals
July 2011

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