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Post-operative (IV)
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Protocol ID
MNTX 3301
NCT ID
NCTXXXXXXXX
Brief Title
A study evaluating intravenous methylnaltrexone bromide for the treatment of post-operative Ileus (POI) in patients undergoing abdominal surgery (segmental colectomy)
Official Title
A Phase 3, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Intravenous (IV) methylnaltrexone bromide in the treatment of Post-Operative Ileus (POI)
Brief Summary
The primary objective of this study is to assess the efficacy of IV methylnaltrexone Bromide in patients undergoing abdominal surgery and receiving opioid therapy for analgesia. Efficacy will be assessed by demonstrating that the time to a patient's first bowel movement and eventual hospital discharge is less in patients treated with IV methylnaltrexone relative to those patients treated with placebo. Additionally, the safety of IV methylnaltrexone bromide, given to patients after abdominal surgery, will be assessed.
Study Phase
Phase 3
Overall Recruitement Status
Ongoing
Study Type: Interventional
Primary Outcomes
The time between the end of surgery and the patient's first bowel movement
Secondary Outcomes
Interventions
DRUG : Intravenous Methylnaltrexone Bromide
Condition(s)
Postoperative Ileus
Eligibility Criteria
Inclusion Criteria:
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Male, female patients ≥ 18 years
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Patients scheduled for segmental hemicolectomy via open laparotomy with general anesthesia.
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Patients must be receiving, or ordered to receive, opioids (morphine, hydromorphone) via patient-controlled analgesia (PCA)
Exclusion Criteria:
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Patients scheduled for laparoscopic surgery for segmental colectomy
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Patients undergoing operations resulting in gastrointestinal ostomies
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Patients taking tricyclic antidepressants
Gender
Male and Female
Minimum Age
18 Years
Maximum Age
None Years
Target Number of Subjects
495
Additional details regarding the clinical trial are available at www.clinicaltrials.gov.
Have a question about our clinical trials? Send an email to clintrialparticipation@wyeth.com.