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This study has been withdrawn prior to enrollment.
(Withdrawn [This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.)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:
Salix Pharmaceuticals
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Salix Pharmaceuticals:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Unknown, Tarbes, France, 65000
Pfizer Investigational Site
Villejuif Cedex, France, 94804
Spain
Pfizer Investigational Site
El Palmar, Murcia/Spain, Spain, 30120
Sponsors and Collaborators
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Jeff Cohn Salix Pharmaceuticals
  More Information

Additional Information:
No publications provided

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
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Egypt: Institutional Review Board
Egypt: Ministry of Health and Population
European Union: European Medicines Agency
Malaysia: Ministry of Health
Philippines: Department of Health
Philippines: Bureau of Food and Drugs
Saudi Arabia: Ministry of Health
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
United Arab Emirates: General Authority for Health Services for Abu Dhabi
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Salix Pharmaceuticals:
opioid induced constipation
Cancer patients
methylnaltrexone

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

ClinicalTrials.gov processed this record on July 26, 2014