Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI).

This study is ongoing, but not recruiting participants.

First Received: November 16, 2006 Last Updated: March 27, 2008 History of Changes

Sponsored by:	Progenics Pharmaceuticals, Inc.
Information provided by:	Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00401375

Purpose

To evaluate the safety and efficacy of MNTX in patients who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.

Condition	Intervention	Phase
Post-Operative Ileus (POI)	Drug: Methylnaltrexone	Phase III

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

Resource links provided by NLM:

Drug Information available for: Methylnaltrexone bromide Methylnaltrexone

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Selected Inclusion Criteria:

Male and female patients at least 18 years of age
Patients must meet ASA physical status I, II, or III
Patient must sign an ICF
Patients must be scheduled for a segmental colectomy
Females of childbearing potential must have a negative serum pregnancy test at the screening visit
Negative for history of chronic active hepatitis B, HCV or HIV infection

Selected Exclusion Criteria:

Patients who received any investigational new drug in the previous 30 days
Females who are pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401375

Locations

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

Sponsors and Collaborators

Progenics Pharmaceuticals, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	MNTX 3301
Study First Received:	November 16, 2006
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00401375 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Intestinal Obstruction
Ileus
Digestive System Diseases
Bromides
Gastrointestinal Diseases
Narcotic Antagonists

Naltrexone
Methylnaltrexone
Narcotics
Peripheral Nervous System Agents
Intestinal Diseases

Additional relevant MeSH terms:

Gastrointestinal Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Intestinal Diseases
Pharmacologic Actions
Intestinal Obstruction
Ileus

Digestive System Diseases
Sensory System Agents
Therapeutic Uses
Naltrexone
Methylnaltrexone
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009