ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain

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.
ClinicalTrials.gov Identifier: NCT01186770
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : November 8, 2013
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in order to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in subjects with chronic, non-malignant pain.

Condition or disease Intervention/treatment Phase
Opioid-Induced Constipation Drug: Methylnaltrexone bromide Drug: Oral Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone (OM) for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic, Non-Malignant Pain
Study Start Date : September 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Active Treatment
Drug: Methylnaltrexone bromide
oral tablets
Experimental: Arm 2
Active Treatment
Drug: Methylnaltrexone bromide
oral tablets
Experimental: Arm 3
Active Treatment
Drug: Methylnaltrexone bromide
oral tablets
Placebo Comparator: Arm 4
Oral Placebo
Drug: Oral Placebo
oral tablets



Primary Outcome Measures :
  1. Proportion of subjects with rescue-free laxation [ Time Frame: 1 Year ]
    (1) rescue-free laxation after first dose of study drug, and (2) rescue-free laxation per subject after all doses during the first four weeks of dosing.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. History of chronic non-malignant pain (originating from a non-malignant source).
  2. Taking oral, transdermal, intravenous, or subcutaneous opioids for chronic non-malignant pain.
  3. No known history of chronic constipation prior to the initiation of opioid therapy.
  4. Currently taking laxative therapy and willing to discontinue all laxative therapy pre-study and use only study-permitted rescue laxatives.

Key Exclusion Criteria:

  1. Prior treatment with oral methylnaltrexone.
  2. Prior treatment with SC methylnaltrexone within 30 days pre-study.
  3. Women who are pregnant, breastfeeding, or plan to become pregnant.
  4. Gastrointestinal disorders known to affect bowel transit.
  5. Current treatment with partial opioid agonists (e.g., buprenorphine) or combination agonists/antagonists.

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): NCT01186770


Locations
United States, North Carolina
PRA International
Raleigh, North Carolina, United States, 27612
PRA, Intl.
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Tage Ramakrishna, M.D. Progenics Pharmaceuticals, Inc.

Responsible Party: Tage Ramakrishna, M.D., Vice President Clinical Research, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01186770     History of Changes
Other Study ID Numbers: MNTX 3201
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Treatment of Opioid-Induced Constipation in Subjects with Chronic, Non-Malignant Pain

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Bromides
Methylnaltrexone
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Narcotic Antagonists