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Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00387309
First received: October 11, 2006
Last updated: July 22, 2011
Last verified: July 2011

October 11, 2006
July 22, 2011
December 2006
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00387309 on ClinicalTrials.gov Archive Site
Not Provided
Secondary Objectives: to assess the safety of IV MOA-728 administered every six hours in these post-surgical subjects; to assess the effects of IV MOA-728 on the time from the end of surgery to discharge eligibility and time to hospital discharge
Not Provided
Not Provided
 
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Post Operative Bowel Dysfunction
Drug: Methylnaltrexone (MOA-728)
Not Provided
Yu CS, Chun HK, Stambler N, Carpenito J, Schulman S, Tzanis E, Randazzo B. Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2011 May;54(5):570-8. doi: 10.1007/DCR.0b013e3182092bde.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
495
November 2007
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Former Serbia and Montenegro,   Germany,   Hungary,   Italy,   Korea, Republic of,   Poland,   Romania,   South Africa
 
NCT00387309
3200L2-300
Not Provided
Jeff Cohn, Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Study Director: Jeff Cohn Salix Pharmaceuticals
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP