Study of Methylnaltrexone (MNTX) for the Relief of Constipation - Full Text View

Study of Methylnaltrexone (MNTX) for the Relief of Constipation

This study has been completed.

Sponsored by:	Progenics Pharmaceuticals, Inc.
Information provided by:	Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00402038

Purpose

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

Condition	Intervention	Phase
Constipation	Drug: Methylnaltrexone	Phase III

MedlinePlus related topics:

Constipation

ChemIDplus related topics:

Methylnaltrexone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Progenics Pharmaceuticals, Inc.:

Primary Outcome Measures:

Co-primary efficacy endpoints: Laxation within four hours of the first dose of study drug

Secondary Outcome Measures:

Secondary efficacy endpoints:Laxation within four hours post-dosing for at least four of the seven doses

Study Start Date:	February 2004
Study Completion Date:	October 2005

Eligibility

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Study ID Numbers:	MNTX 302
First Received:	November 17, 2006
Last Updated:	July 19, 2007
ClinicalTrials.gov Identifier:	NCT00402038
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Signs and Symptoms, Digestive

Naltrexone

Constipation

Methylnaltrexone

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Narcotic Antagonists

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008