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

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. Identifier: NCT00640146
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : July 19, 2011
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Valeant Pharmaceuticals International, Inc.

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

Condition or disease Intervention/treatment Phase
Opioid-induced Constipation Drug: Methylnaltrexone bromide Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
MNTX bromide (MOA-728)
Drug: Methylnaltrexone bromide
Subcutaneous Methylnaltrexone

Placebo Comparator: 2
Placebo Comparator
Drug: Placebo
Subcutaneous Placebo

Primary Outcome Measures :
  1. The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 4 or 7 days ]

Information from the National Library of Medicine

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

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).

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 identifier (NCT number): NCT00640146

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alton B. Kremer, MD, PhD, Sr. Vice President, Clinical Research, Progenics Pharmaceuticals, Inc. Identifier: NCT00640146     History of Changes
Other Study ID Numbers: MNTX2101
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents