Study of Methylnaltrexone (MNTX) for the Relief of Constipation

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00402038
First received: November 17, 2006
Last updated: July 18, 2011
Last verified: July 2011

November 17, 2006
July 18, 2011
February 2004
October 2005   (final data collection date for primary outcome measure)
Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours.

To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.

Not Provided
Complete list of historical versions of study NCT00402038 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Methylnaltrexone (MNTX) for the Relief of Constipation
A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Advance Illness Patients With OIC
  • Drug: SC Methylnaltrexone
    Dose 1
  • Drug: SC Placebo
  • Experimental: Arm 1
    Intervention: Drug: SC Methylnaltrexone
  • Placebo Comparator: Arm 2
    Intervention: Drug: SC Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age and older
  • Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
  • Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
  • patient must sign ICF

Exclusion Criteria:

  • Women who are pregnant and/or nursing
  • Previous treatment with MNTX
  • Participation in any other studies involving investigational products within 30 days prior to screening
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00402038
MNTX 302
Yes
Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
July 2011

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