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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00401375
First received: November 16, 2006
Last updated: July 17, 2011
Last verified: July 2011
History of Changes
  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
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Time between the end of surgery and the subject's first bowel movement [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
    Test the hypothesis that the time between the end of surgery and first bowel movement is significantly shorter in the MNTX regimen than the placebo regimen


Enrollment: 515
Study Start Date: October 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
MNTX Active Treatment
 Drug: Methylnaltrexone
Intravenous MNTX
Experimental: Arm 2
MNTX Active Treatment
 Drug: Methylnaltrexone
Intravenous MNTX
Placebo Comparator: Arm 3
Placebo
 Drug: Placebo
Intravenous

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Salix Pharmaceuticals
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Salix Pharmaceuticals

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

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00401375     History of Changes
Other Study ID Numbers: MNTX 3301
Study First Received: November 16, 2006
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Methylnaltrexone
Naltrexone
 Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013