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Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367574
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Number of subjects who have a bowel movement within four hours of dosing [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367574

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

No publications provided

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367574     History of Changes
Other Study ID Numbers: MNTX 251
Study First Received: May 27, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Opioid-induced bowel dysfunction

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

ClinicalTrials.gov processed this record on May 16, 2013