A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group Study of Alvimopan for the Prevention or Reduction of Opioid-Induced Gastrointestinal Side Effects in Subjects Undergoing Ambulatory Shoulder Surgery

Institutional Review Board, Hospital for Special Surgery

January 02, 2007

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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Principal Investigator

Frank A. Cordasco, MD

Co-Investigators

David W. Altchek, MD
Edward V. Craig, MD
Scott A. Rodeo, MD
Russell F. Warren, MD

Summary

The primary objective of this study is to demonstrate the safety and efficacy of alvimopan in preventing or reducing GI side effects in subjects taking oral opioids (hydrocodone/acetaminophen) for acute pain management after ambulatory shoulder surgery.  A secondary objective is to assess the effects of alvimopan on opioid symptom distress and other subject-reported outcomes.

Approximately 300 subjects are to be enrolled across 30 study centers nationwide; approximately 10 subjects are to be enrolled at the Hospital for Special Surgery.  Once enrolled, the duration of the study and the follow-up include a baseline screening period of one week prior to surgery, the first two weeks following surgery, and a phone call at approximately six weeks following surgery; a total of 5 weeks.  Subjects will undergo 4 study-related visits, consisting of 2 sets of blood tests, 2 physical exams, patient questionnaires, and daily reporting of GI symptoms in a study diary (which will be provided).  Some subjects will receive the investigational medication, while others will receive a placebo.

Inclusion/Exclusion Criteria

Major Inclusion Criteria

1. Subject must be between 18-80 years of age.
2. Subject must be scheduled for ambulatory surgery for either open/mini-open or arthroscopic rotator cuff repair, and is scheduled to receive opioid analgesia for postdischarge pain management.
3. If female, subject is postmenopausal, or, if of childbearing potential, is using an accepted method of birth control for the duration of the study; subject must also have a negative urine pregnancy test on day of surgery.
4. Subject must be able to read, write, and fully understand English. 

Major Exclusion Criteria

1. Subject is scheduled for a revision of a failed rotator cuff repair, or has an acute dislocation or fracture of the glenohumeral joint.
2. Subject has a colostomy or ileostomy.
3. Subject has diagnosed history of constipation, pelvic floor disorders, or GI disorders known to affect bowel function (i.e. irritable bowel syndrome, inflammatory bowel disease, functional constipation, benign abdominal/pelvic mass).
4. Subject is currently receiving chronic/acute opioid therapy for pain management, or has clinically significant abnormal laboratory results.
5. Subject is apprehensive about taking opioid medication.

Contact Information

Kathryn Fong
Clinical Research Assistant
Sports Medicine and Shoulder Service
Belaire 7I
fongk@hss.edu
212.774.7524