Clinical trial NCT01258569: Entereg Laparoscopic Colon Resection Study
Official title: Entereg Laparoscopic Colon Resection Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Laparoscopic Colonic Resection
Keywords: laparoscopic
colon
resection
Entereg
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
First posted: 2010-12-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been shown to increase postoperative bowel function in patients after open bowel resection surgery. It has been proven safe and effective for short-term in-house treatment. At the present there are several Drug Use Utilization Evaluation studies reporting results involving the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study will be the first randomized, prospective, double-blind, placebo-controlled trial looking at this population. We propose that Entereg will decrease the length of stay by one day in the laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2 recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery (toleration of solid food, and flatus or bowel movement) will be secondary endpoints.

Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date: May 2012, Estimated Primary Completion Date: Nov 2011.


Eligibility criteria: Inclusion Criteria:

Subject is scheduled to undergo laparoscopic (straight or hand assisted) elective colon resection with primary anastamosis Subject is \>18 years of age Subjects can be either male or female Negative pregnancy test (if patient is a premenopausal female) Medically stable as determined by the treating surgeon- i.e., subject has an American Society of Anesthesiologists Physical Status Score of I to III.

Subject understands the study procedures, agrees to participate in the study as per the study protocol, and has voluntarily provided informed consent Patients who will be receiving IV Opioid therapy post surgery for pain management.

Exclusion Criteria:

Subject is pregnant or lactating Subject is currently using opioids or has taken more than 3 doses of opioids (oral or parenteral) in the week prior to surgery.

Subject has complete bowel obstruction Subject is not able to understand the informed consent document or is unable to give informed consent Patients who will receive a thoracic epidural for pain management post surgery. Subject has any medical instability or any condition at screening/enrollment which, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject during the administration of study procedures.

Primary outcomes:
measure: length of stay in days
timeFrame: 7-10 days s/p discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
References: