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Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367574
First Posted: June 7, 2011
Last Update Posted: July 19, 2011
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.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  Purpose
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

Condition Intervention Phase
Bowel Dysfunction Drug: SC MNTX Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Number of subjects who have a bowel movement within four hours of dosing [ Time Frame: Up to 4 weeks ]
    To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.


Secondary Outcome Measures:
  • Number of subject with Adverse Events [ Time Frame: Up to 4 weeks ]
    To access the tolerability of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.


Enrollment: 39
Study Start Date: April 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: SC MNTX
Dose 1
Experimental: Arm 2 Drug: SC MNTX
Dose 2
Experimental: Arm 3 Drug: SC MNTX
Dose 3

  Eligibility

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
Criteria

Inclusion Criteria:

  1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
  2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
  3. Must have constipation
  4. Must be 18 yrs or older

Exclusion Criteria:

  1. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
  2. Patients who received any experimental drug in the last 30 days
  3. Patients with active peritoneal cancer (ovarian, etc.)
  4. Patients with active diverticulitis or diverticulosis
  Contacts and Locations
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): NCT01367574


Locations
United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367574     History of Changes
Other Study ID Numbers: MNTX 251
First Submitted: May 27, 2011
First Posted: June 7, 2011
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Opioid-induced bowel dysfunction

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Opioid
Methylnaltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists