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Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

This study has been completed.
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00387309
First received: October 11, 2006
Last updated: July 22, 2011
Last verified: July 2011
  Purpose
Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

Condition Intervention Phase
Post Operative Bowel Dysfunction Drug: Methylnaltrexone (MOA-728) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the MOA-728 regimen than with a placebo regimen.

Estimated Enrollment: 495
Study Start Date: December 2006
Study Completion Date: November 2007
  Eligibility

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

Inclusion:

  • Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia
  • Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met
  • Subjects must meet the American Society of Anesthesiologists physical status I, II or III

Exclusion:

  • Subjects who are scheduled for laparoscopic surgery for the segmental colectomy
  • Subjects with a recent history (<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)
  • Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)
  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: NCT00387309

  Show 92 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00387309     History of Changes
Other Study ID Numbers: 3200L2-300
Study First Received: October 11, 2006
Last Updated: July 22, 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Bowel

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

ClinicalTrials.gov processed this record on June 23, 2017