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

Sponsors and Collaborators:	Progenics Pharmaceuticals, Inc. Wyeth
Information provided by:	Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00640146

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	Phase II

MedlinePlus related topics: Constipation Rehabilitation

Drug Information available for: Methylnaltrexone bromide Methylnaltrexone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by Progenics Pharmaceuticals, Inc.:

Primary Outcome Measures:

The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	260
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MNTX bromide (MOA-728)	Drug: Methylnaltrexone bromide
2: Placebo Comparator Placebo Comparator	Drug: Methylnaltrexone bromide

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:

Male and female subjects ³ 18 years of age.
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).
Subjects must be receiving opioid medication for pain relief after the procedures
Subjects must be constipated following their orthopedic procedure
Subjects must receive all the doses of study drug in either a hospital or a rehabilitation facility.
Subjects must sign an informed consent form.
Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
Body weight within range of 40 kg - 150 kg (88 - 330 lbs).

Exclusion Criteria:

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

Contacts and Locations

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

Progenics Pharmaceuticals, Inc.

Wyeth

Investigators

Study Director:

Stephen Morris, MD PhD

Progenics Pharmaceuticals, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Progenics Pharmaceuticals, Inc. ( Alton B. Kremer, MD, PhD, Sr. Vice President, Clinical Research )
Study ID Numbers:	MNTX2101
Study First Received:	March 18, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00640146 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Bromides
Narcotic Antagonists
Naltrexone

Constipation
Methylnaltrexone
Narcotics
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Naltrexone
Constipation
Methylnaltrexone
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009