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

This study has been withdrawn prior to enrollment.
(Withdrawn [This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.)
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00858754
First received: March 9, 2009
Last updated: July 22, 2011
Last verified: July 2011
  Purpose
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 Intervention Phase
Opioid-Induced Constipation Drug: methylnaltrexone Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • 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. 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 ]

Estimated Enrollment: 340
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Active Drug
Methylnaltrexone
Drug: methylnaltrexone
Other Name: MOA-728
Placebo Comparator: Group 2 Non-Active Drug
Placebo
Drug: placebo
Other Name: Inactive

  Eligibility

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

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.
  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: NCT00858754

Locations
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
France
Pfizer Investigational Site
Villejuif Cedex, France, 94804
Spain
Pfizer Investigational Site
El Palmar, Murcia/Spain, Spain, 30120
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
  More Information

Additional Information:
Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00858754     History of Changes
Other Study ID Numbers: 3200K1-4006
Study First Received: March 9, 2009
Last Updated: July 22, 2011

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

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

ClinicalTrials.gov processed this record on June 23, 2017