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A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00401362
First received: November 16, 2006
Last updated: July 18, 2011
Last verified: July 2011
History of Changes

November 16, 2006
July 18, 2011
February 2003
February 2005   (final data collection date for primary outcome measure)
Efficacy of SC MNTX compared with placebo in inducing laxation [ Time Frame: 29 days ] [ Designated as safety issue: No ]
The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.
Not Provided
Complete list of historical versions of study NCT00401362 on ClinicalTrials.gov Archive Site
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A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients
A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness

To test the effectiveness of MNTX in advanced illness subjects.

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Advanced Illness Patients With Opioid Induced Constipation
  • Drug: SC Methylnaltrexone
    Dose 1
  • Drug: SC Placebo
  • Drug: SC Methylnaltrexone
    Dose 2
  • Experimental: Arm 1
    Intervention: Drug: SC Methylnaltrexone
  • Placebo Comparator: Arm 3
    Intervention: Drug: SC Placebo
  • Experimental: Arm 2
    Intervention: Drug: SC Methylnaltrexone
Slatkin N, Thomas J, Lipman AG, Wilson G, Boatwright ML, Wellman C, Zhukovsky DS, Stephenson R, Portenoy R, Stambler N, Israel R. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009 Jan-Feb;7(1):39-46.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
February 2005
February 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Advanced medical illness with a life expectancy of 1 to 6 months
  2. No clinically significant laxation within 48 hours prior to the first dose of study drug
  3. On stable opioid and laxative regimen for a least 3 days prior to treatment
  4. Age greater than 18years
  5. Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria:

  1. Females who are pregnant or nursing.
  2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
  3. Any disease process suggestive of gastrointestinal obstruction
  4. Fecal ostomy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00401362
MNTX 301
Yes
Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
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