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

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ClinicalTrials.gov Identifier: NCT00605644
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : July 28, 2011
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by:
Valeant Pharmaceuticals International, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Constipation Drug: MOA-728 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Spontaneous Bowel Movements [ Time Frame: App. 1 month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00605644


Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
More Information
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Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00605644     History of Changes
Other Study ID Numbers: 3200A3-2202
First Posted: January 31, 2008    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

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