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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This study has been withdrawn prior to enrollment.
(Withdrawn [This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.)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:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00858754
First received: March 9, 2009
Last updated: July 22, 2011
Last verified: July 2011
History of Changes

March 9, 2009
July 22, 2011
March 2009
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00858754 on ClinicalTrials.gov Archive Site
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 ]
  • Bowel movements within 4 hours after at least 2 of the first 4 doses. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Bowel movements within 4 hours after all doses. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The time to bowel movement after the first dose. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Opioid-Induced Constipation
  • Drug: methylnaltrexone
    Other Name: MOA-728
  • Drug: placebo
    Other Name: Inactive
  • Experimental: Group 1 Active Drug
    Methylnaltrexone
    Intervention: Drug: methylnaltrexone
  • Placebo Comparator: Group 2 Non-Active Drug
    Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
340
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Spain
 
NCT00858754
3200K1-4006
No
Jeff Cohn, Salix Pharmaceuticals
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Study Director: Jeff Cohn Salix Pharmaceuticals
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP