Study Evaluating Long-Term Safety Of MOA-728 In Subjects With Opioid-Induced Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804141
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
This is a one-year study to evaluate the long-term safety and tolerability of the subcutaneous (just under the skin) injection form of MOA-728 for the treatment of opioid-induced constipation in subjects with nonmalignant pain. The study consists of a 2 week screening period, a 48 week open-label treatment period and a 2 week follow-up period. Subjects will need to agree to self-administer subcutaneous injections, complete daily diaries, and check-in via a daily telephone call during that year-long period.

Condition or disease Intervention/treatment Phase
Constipation Drug: N-methylnaltrexone bromide (MOA-728) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1040 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study To Evaluate The Long-Term Safety Of Subcutaneous MOA-728 For Treatment Of Opioid-Induced Constipation In Subjects With Nonmalignant Pain
Study Start Date : December 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: N-methylnaltrexone bromide (MOA-728)
48 week treatment with 12 mg MOA-728 administered subcutaneously at least once per week with a maximum frequency of once daily.
Other Name: Relistor

Primary Outcome Measures :
  1. collection of safety data & assessments to include monitoring of treatment emergent adverse events, safety laboratory measurements, electrocardiograms and changes in the physical exam including vital signs while on therapy [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. change in bowel function compared to baseline [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • men and women 18 years or older,
  • history of pain of at least 2 months duration before study entry due to documented underlying nonmalignant condition,
  • history of constipation due to opioid use for the nonmalignant condition,

Exclusion Criteria:

  • diagnosis of significant GI disorder such as bowel obstruction, fecal incontinence or rectal prolapse for example,
  • history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before study entry,
  • history of malignancy or chronic constipation before initiation of opioid therapy.

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 identifier (NCT number): NCT00804141

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Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: James Joffrion Valeant Pharmaceuticals International, Inc.

Additional Information:
Publications of Results:
Webster R, Michna E, Khan A, et al., The long-term efficacy of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain. J. Pain, 12(4), Supplement , Page P70, April 2011

Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT00804141     History of Changes
Other Study ID Numbers: 3200K1-3358
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: June 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
treatment for opioid-induced constipation

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists