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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01186770
First received: August 19, 2010
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Opioid-Induced Constipation
Drug: Methylnaltrexone bromide
Drug: Oral 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, 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

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of subjects with rescue-free laxation [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    (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.


Estimated Enrollment: 700
Study Start Date: September 2010
Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: 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
Salix Pharmaceuticals
Investigators
Study Director: Tage Ramakrishna, M.D. Progenics Pharmaceuticals, Inc.
  More Information

No publications provided

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
Study First Received: August 19, 2010
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Treatment of Opioid-Induced Constipation in Subjects with Chronic, Non-Malignant Pain

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

ClinicalTrials.gov processed this record on July 26, 2014