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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00388258
Other study ID # 3753-015
Secondary ID 14CL302
Status Completed
Phase Phase 3
First received October 13, 2006
Last updated August 17, 2017
Start date March 1, 2001
Est. completion date December 1, 2002

Study information

Verified date August 2017
Source Cubist Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 451
Est. completion date December 1, 2002
Est. primary completion date December 1, 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject is scheduled for a partial small/large bowel resection of primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy

- Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids

Exclusion Criteria:

- Subject is scheduled for a total colectomy, colostomy, ileostomy

- Subject has complete bowel obstruction

- Subject is currently taking opioid analgesics or has taken opioid analgesics within 4 weeks prior to surgery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Alvimopan


Locations

Country Name City State
United States Various Exton Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Cubist Pharmaceuticals LLC GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA; Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major ab — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary acceleration of gastrointestinal recovery
Secondary time until ready for discharged based upon recovery of GI function
Secondary severity of GI symptoms
Secondary pain
Secondary opioid consumption
Secondary time to tolerate solid food
Secondary need for reinsertion of nasogastric tube
Secondary time until discharge order is written
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