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

This study has been completed.
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
First received: November 16, 2006
Last updated: July 18, 2011
Last verified: July 2011
To test the effectiveness of MNTX in advanced illness subjects.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Efficacy of SC MNTX compared with placebo in inducing laxation [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    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.

Enrollment: 154
Study Start Date: February 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: SC Methylnaltrexone
Dose 1
Placebo Comparator: Arm 3 Drug: SC Placebo
Experimental: Arm 2 Drug: SC Methylnaltrexone
Dose 2

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00401362

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

No publications provided by Valeant Pharmaceuticals International, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00401362     History of Changes
Other Study ID Numbers: MNTX 301
Study First Received: November 16, 2006
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2015