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

2014-08-27 03:42:02 | BioPortfolio

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, 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).

Description

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.

Study Design

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

Conditions

Ileus

Intervention

Alvimopan

Location

Various
Exton
Pennsylvania
United States
19341

Status

Completed

Source

Adolor Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:02-0400

Clinical Trials [68 Associated Clinical Trials listed on BioPortfolio]

A Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy

This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objec...

Study of Alvimopan for the Management of 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 dis...

Study of Alvimopan for the Management of 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 dis...

Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperit...

Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Standard of Care in the Premier Perspective Database

Alvimopan is the first and currently the only FDA-approved therapy for acceleration of the time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel res...

PubMed Articles [36 Associated PubMed Articles listed on BioPortfolio]

Alvimopan usage increasing following radical cystectomy.

Alvimopan (Entereg), a peripherally acting opioid receptor antagonist, is effective in reducing the rate of postoperative ileus and length of hospital stay in patients undergoing colorectal surgery, a...

The Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery (SPOT), A Randomized Controlled Trial.

Postoperative ileus is a poorly understood multifactorial outcome following colorectal surgery that presents significant clinical challenges and contributes to increased morbidity, length of stay, and...

Intestinal manipulation affects mucosal antimicrobial defense in a mouse model of postoperative ileus.

To explore the effects of abdominal surgery and interleukin-1 signaling on antimicrobial defense in a model of postoperative ileus.

Quetiapine Related Acute Paralytic Ileus in a Bipolar I Disorder Patient with Successful Low Dose Amisulpride Substitution: A Case Report.

The mechanism of medication-induced gastrointestinal hypomotility is primarily caused by muscarinic cholinergic antagonism. This effect may cause constipation and paralytic ileus, which may lead to fa...

Laparoscopic management for gallstone ileus, case report.

Gallstone ileus is a rare complication of cholelithiasis leading to small intestinal obstruction. Elderly females are commonly affected more than male. The diagnosis of this condition is challenging a...

Medical and Biotech [MESH] Definitions

A condition caused by the lack of intestinal PERISTALSIS or INTESTINAL MOTILITY without any mechanical obstruction. This interference of the flow of INTESTINAL CONTENTS often leads to INTESTINAL OBSTRUCTION. Ileus may be classified into postoperative, inflammatory, metabolic, neurogenic, and drug-induced.

Intestinal obstruction caused by congealed MECONIUM in the distal ILEUM and CECUM. It presents shortly after birth as a failure to pass meconium and frequently occurs in infants with CYSTIC FIBROSIS.

A type of ILEUS, a functional not mechanical obstruction of the INTESTINES. This syndrome is caused by a large number of disorders involving the smooth muscles (MUSCLE, SMOOTH) or the NERVOUS SYSTEM.

Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.

A specific decapeptide obtained from the skin of Hila caerulea, an Australian amphibian. Caerulein is similar in action and composition to CHOLECYSTOKININ. It stimulates gastric, biliary, and pancreatic secretion; and certain smooth muscle. It is used in paralytic ileus and as diagnostic aid in pancreatic malfunction.

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