Entereg Laparoscopic Colon Resection Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258569
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : August 26, 2015
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Hartford Hospital

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Colonic Resection Drug: Entereg Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Entereg Laparoscopic Colon Resection Study
Study Start Date : November 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alvimopan

Arm Intervention/treatment
Active Comparator: Entereg Drug: Entereg
Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI recovery in after partial large or small bowel resection surgery with primary anastomosis.

Drug: Entereg
oral, 12 mg 30-300 min pre-op then BID up to 7 days (or 15 total doses)

Placebo Comparator: Placebo Drug: placebo
12 mg oral 30-300 min pre-op then BID up to 7 days (or 15 doses)

Primary Outcome Measures :
  1. length of stay in days [ Time Frame: 7-10 days s/p discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01258569

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
Sponsors and Collaborators
Hartford Hospital
Cubist Pharmaceuticals LLC

Responsible Party: Hartford Hospital Identifier: NCT01258569     History of Changes
Other Study ID Numbers: JOHN002914HE
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Hartford Hospital:

Additional relevant MeSH terms:
Gastrointestinal Agents