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

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ClinicalTrials.gov Identifier: NCT00401375
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : July 19, 2011
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Post-Operative Ileus (POI) Drug: Methylnaltrexone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : October 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time between the end of surgery and the subject's first bowel movement [ Time Frame: Up to 10 days ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401375


Locations
United States, New York
Progenics Pharmaceuticals
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.

Additional Information:
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
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bromides
Methylnaltrexone
Naltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents