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.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
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.
Major Inclusion Criteria
Major Exclusion Criteria
Clinical Research Assistant
Sports Medicine and Shoulder Service