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

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by:

Valeant Pharmaceuticals International, Inc.

ClinicalTrials.gov Identifier:

NCT00401362

First received: November 16, 2006

Last updated: July 18, 2011

Last verified: July 2011

History of Changes

Purpose

To test the effectiveness of MNTX in advanced illness subjects.

Condition	Intervention	Phase
Advanced Illness Patients With Opioid Induced Constipation	Drug: SC Methylnaltrexone Drug: SC Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Methylnaltrexone

U.S. FDA Resources

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:

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.


Enrollment:	154
Study Start Date:	February 2003
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: SC Methylnaltrexone Dose 1
Placebo Comparator: Arm 3	Drug: SC Placebo
Experimental: Arm 2	Drug: SC Methylnaltrexone Dose 2

Detailed Description:

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Females who are pregnant or nursing.
Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
Any disease process suggestive of gastrointestinal obstruction
Fecal ostomy.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401362

Locations


United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591

Sponsors and Collaborators

Valeant Pharmaceuticals International, Inc.

Pfizer

Investigators


Study Director:	Tage Ramakrishna, MD	Progenics Pharmaceuticals, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. Epub 2016 Aug 29.

Nalamachu SR, Pergolizzi J, Taylor R Jr, Slatkin NE, Barrett AC, Yu J, Bortey E, Paterson C, Forbes WP. Efficacy and Tolerability of Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: A Responder Analysis of 2 Randomized, Placebo-Controlled Trials. Pain Pract. 2015 Jul;15(6):564-71. doi: 10.1111/papr.12218. Epub 2014 May 10.

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.


Responsible Party:	Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00401362 History of Changes
Other Study ID Numbers:	MNTX 301
Study First Received:	November 16, 2006
Last Updated:	July 18, 2011

Additional relevant MeSH terms:


Constipation Signs and Symptoms, Digestive Signs and Symptoms Methylnaltrexone Naltrexone	Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 17, 2017

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