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Trial record 1 of 1 for:    NCT00401362
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A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00401362
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by:
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE November 16, 2006
First Posted Date  ICMJE November 20, 2006
Last Update Posted Date November 25, 2019
Study Start Date  ICMJE February 2003
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
Efficacy of SC MNTX compared with placebo in inducing laxation [ Time Frame: 29 days ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients
Official Title  ICMJE 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
Brief Summary To test the effectiveness of MNTX in advanced illness subjects.
Detailed Description To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Advanced Illness Patients With Opioid Induced Constipation
Intervention  ICMJE
  • Drug: SC Methylnaltrexone
    Dose 1
  • Drug: SC Placebo
  • Drug: SC Methylnaltrexone
    Dose 2
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: SC Methylnaltrexone
  • Placebo Comparator: Arm 3
    Intervention: Drug: SC Placebo
  • Experimental: Arm 2
    Intervention: Drug: SC Methylnaltrexone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)
154
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2005
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00401362
Other Study ID Numbers  ICMJE MNTX 301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date November 2019

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