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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00401362
First received: November 16, 2006
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

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 Salix Pharmaceuticals:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Salix Pharmaceuticals

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:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014