Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

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: NCT00858754
Recruitment Status : Withdrawn (Withdrawn [This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.)
First Posted : March 10, 2009
Last Update Posted : July 25, 2011
Progenics Pharmaceuticals, Inc.
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Condition or disease Intervention/treatment Phase
Opioid-Induced Constipation Drug: methylnaltrexone Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
Study Start Date : March 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1 Active Drug
Drug: methylnaltrexone
Other Name: MOA-728
Placebo Comparator: Group 2 Non-Active Drug
Drug: placebo
Other Name: Inactive

Primary Outcome Measures :
  1. Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. [ Time Frame: 1 Day ]

Secondary Outcome Measures :
  1. 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose. [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Is a man or woman aged 18 years or older.
  • Has a body weight >= 38 kg.
  • Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
  • Has a life expectancy of >= 6 months.
  • Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Is taking opioids for cancer-related pain, and not just as-needed doses.
  • Has a diagnosis of OIC as determined by the investigator.
  • Is willing to follow the protocol instructions on laxative use during the study.

Exclusion Criteria:

  • Has a history of chronic constipation before starting opioids.
  • Has renal disease receiving dialysis.
  • Has an ostomy for stools.
  • Is a pregnant or breastfeeding woman.

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): NCT00858754

United States, California
Pfizer Investigational Site
Laguna Hills, California, United States, 92637
Pfizer Investigational Site
Lancaster, California, United States, 93534
United States, North Carolina
Pfizer Investigational Site
Flat Rock, North Carolina, United States, 28731
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Pfizer Investigational Site
Villejuif Cedex, France, 94804
Pfizer Investigational Site
El Palmar, Murcia/Spain, Spain, 30120
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Progenics Pharmaceuticals, Inc.
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.

Additional Information:
Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00858754     History of Changes
Other Study ID Numbers: 3200K1-4006
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
opioid induced constipation
Cancer patients

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