NCT01150760

Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database

Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,050 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 resection surgery with primary anastomosis. The primary objective of this retrospective observational trial is to assess postoperative morbidity and mortality as reported during the index hospitalization for bowel resection and 15/30-day readmissions of alvimopan vs. non-alvimopan matched patients in the combined Premier/Care Science database(a large medical claims database).

Conditions

• Ileus

Interventions

Type	Name	Description
DRUG	Alvimopan	At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-06-25
• Last updated: 2015-08-07
• Results posted: 2010-09-08

Locations

1 site across 1 country: United States