A Study Evaluating IV MOA-728 for the Treatment of POI In Subjects After Ventral Hernia Repair

This study is currently recruiting participants.

Verified by Wyeth, February 2008

Sponsors and Collaborators:	Wyeth Progenics Pharmaceuticals, Inc.
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00528970

Purpose

To assess, in subjects who have ventral wall hernia repair, the time between the end of surgery and first bowel movement with the investigational MOA-728 regimen as compared with a placebo regimen.

Condition	Intervention	Phase
Ileus	Drug: MOA-728 Other: placebo	Phase III

MedlinePlus related topics: Hernia

Drug Information available for: Methylnaltrexone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus After Ventral Hernia Repair

Further study details as provided by Wyeth:

Primary Outcome Measures:

Primary: The effect of the interventional treatment will be measured by the time to bowel movement. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Other: placebo placebo
2: Experimental	Drug: MOA-728 IV
3: Experimental	Drug: MOA-728 IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females, ages 18 and older.
Scheduled for ventral wall hernia repair with general anesthesia.
Meets the American Society of Anesthesiologists physical status I, II, or III.

Exclusion Criteria:

Received investigational drug or procedure within 30 days of randomization.
Women who are pregnant or lactating.
Calculated creatinine clearance (Cockcroft-Gault GRF) </= 50 mL/min.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528970

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 75 Study Locations

Sponsors and Collaborators

Wyeth

Progenics Pharmaceuticals, Inc.

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3200L2-301
Study First Received:	September 11, 2007
Last Updated:	February 4, 2008
ClinicalTrials.gov Identifier:	NCT00528970
Health Authority:	Australia: National Health and Medical Research Council; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: Ministry of Health; Canada: Health Canada; European Union: European Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Korea: Food and Drug Administration; Mexico: National Institute of Public Health, Health Secretariat; Netherlands: Medicines Evaluation Board (MEB); Poland: Ministry of Health; Romania: State Institute for Drug Control; South Africa: Medicines Control Council; United States: Food and Drug Administration

Keywords provided by Wyeth:

POI
Hernia
Ventral Wall Hernia Repair
Post Operative Ileus

Study placed in the following topic categories:

Intestinal Obstruction
Pathological Conditions, Anatomical
Ileus
Digestive System Diseases
Gastrointestinal Diseases

Hernia
Hernia, Abdominal
Hernia, Ventral
Methylnaltrexone
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009