Clinical Trials Logo
  1. Home
  2. Ileus
  3. NCT00388479

Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/ Postoperative Ileus

Ileus Clinical Trial

Official title:
A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

Clinical Trial Summary

Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

Clinical Trial Description

Postoperative ileus (POI) is a temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown to consistently shorten the duration of POI. This study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of GI function in patients undergoing bowel resection or hysterectomy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00388479
Study type Interventional
Source Cubist Pharmaceuticals LLC
Contact
Status Completed
Phase Phase 3
Start date December 2001
Completion date November 2003
View Details
See also
  Status Clinical Trial Phase
Terminated NCT00065234 - Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus) Phase 2
Completed NCT01156129 - Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery Phase 1
Recruiting NCT05712525 - Gut Recovery In Patients Following Surgery
Completed NCT06338813 - Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus N/A
Recruiting NCT05315765 - Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
Completed NCT02161367 - Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery Phase 4
Completed NCT03711487 - The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection Phase 2
Completed NCT00528970 - A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair Phase 3
Not yet recruiting NCT04001985 - Nasogastric Tube Clamping Trial vs. Immediate Removal N/A
Completed NCT02836470 - A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection Phase 2
Completed NCT04100447 - A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection Phase 1
Active, not recruiting NCT03795467 - Peripheral Perfusion Index, Haemoglobin and Blood Transfusion in Acute Surgical Patients
Completed NCT01143259 - Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use N/A
Terminated NCT03352414 - Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC Phase 2
Not yet recruiting NCT04305730 - Use of Pedometer Following Radical Cystectomy N/A
Completed NCT02760290 - Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique N/A
Active, not recruiting NCT02399605 - Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus N/A
Completed NCT00388258 - Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus Phase 3
Terminated NCT05470387 - A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection Phase 3
Completed NCT00205842 - Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus Phase 3