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

NCT01150760 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7050

Last updated 2015-08-07

Study results available
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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

DRUG

Alvimopan

At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Lee Techner, DPM · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01150760 on ClinicalTrials.gov