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A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

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ClinicalTrials.gov Identifier: NCT00401362
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : July 19, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
To test the effectiveness of MNTX in advanced illness subjects.

Condition or disease Intervention/treatment Phase
Advanced Illness Patients With Opioid Induced Constipation Drug: SC Methylnaltrexone Drug: SC Placebo Phase 3

Detailed Description:
To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness
Study Start Date : February 2003
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: SC Methylnaltrexone
Dose 1
Placebo Comparator: Arm 3 Drug: SC Placebo
Experimental: Arm 2 Drug: SC Methylnaltrexone
Dose 2



Primary Outcome Measures :
  1. Efficacy of SC MNTX compared with placebo in inducing laxation [ Time Frame: 29 days ]
    The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.



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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. Advanced medical illness with a life expectancy of 1 to 6 months
  2. No clinically significant laxation within 48 hours prior to the first dose of study drug
  3. On stable opioid and laxative regimen for a least 3 days prior to treatment
  4. Age greater than 18years
  5. Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria:

  1. Females who are pregnant or nursing.
  2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
  3. Any disease process suggestive of gastrointestinal obstruction
  4. Fecal ostomy.

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): NCT00401362


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