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
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, 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).
Postoperative ileus (POI) is 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 of hysterectomy. ;
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 | |
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 | |
Enrolling by invitation |
NCT05298774 -
Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function
|
N/A |