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Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00640146
First received: March 18, 2008
Last updated: July 17, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.


Condition Intervention Phase
Opioid-induced Constipation
Drug: Methylnaltrexone bromide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 4 or 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: October 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MNTX bromide (MOA-728)
Drug: Methylnaltrexone bromide
Subcutaneous Methylnaltrexone
Placebo Comparator: 2
Placebo Comparator
Drug: Placebo
Subcutaneous Placebo

Detailed Description:

This is a double-blind, randomized, parallel-group, placebo- controlled phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in subjects who have undergone orthopedic procedures and who are expected to require opioids for one week after randomization. Subjects will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those subjects who meet all eligibility requirements will be enrolled in the study. Subjects will be randomly assigned to either a four-day treatment of once daily SC MNTX 12 mg or SC placebo in a 1:1 ratio. Treatment with study medication will begin on the same day as screening, or no later than the following calendar day. All bowel movements and the time of bowel movement will be recorded. Treatment with study medication will be continued until either the subject no longer requires opioid medication for pain relief or a maximum of four days (four doses) of treatment is reached. Subjects will be given patient diaries at the start of the study. Study drug will be transferred from hospitals to rehabilitation facilities for subjects discharged to rehabilitation facilities.

  Eligibility

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

Inclusion Criteria:

  1. Male and female subjects ³ 18 years of age.
  2. Subjects must have undergone an orthopedic procedure (i.e., total knee or hip replacement, spinal fusion or reduction of fracture(s) with or without surgical fixation post trauma).
  3. Subjects must be receiving opioid medication for pain relief after the procedures
  4. Subjects must be constipated following their orthopedic procedure
  5. Subjects must receive all the doses of study drug in either a hospital or a rehabilitation facility.
  6. Subjects must sign an informed consent form.
  7. Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
  8. Body weight within range of 40 kg - 150 kg (88 - 330 lbs).

Exclusion Criteria:

  1. Subjects with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
  2. Subjects who received any investigational new drug (experimental) in the previous 30 days.
  3. Subjects who have received an osmotic laxative (e.g., lactulose) or an enema within 48 hours prior to the first dose.
  4. Subjects who initiated treatment with a stool softener within 24 hours prior to the first dose.
  5. Subjects with constipation not attributed to post procedure opioids
  6. Subjects with a history of alcohol or prescription or non-prescription drug abuse within the past two years.
  7. Female subjects who are pregnant or lactating.
  8. Subjects with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV).
  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: NCT00640146

Locations
United States, New York
Progenics Pharmaceuticals, Inc
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Salix Pharmaceuticals
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided by Salix Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alton B. Kremer, MD, PhD, Sr. Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00640146     History of Changes
Other Study ID Numbers: MNTX2101
Study First Received: March 18, 2008
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive
Methylnaltrexone
Naltrexone
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 20, 2014