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Entereg Laparoscopic Colon Resection Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Hartford Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cubist Pharmaceuticals
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01258569
First received: December 9, 2010
Last updated: February 25, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Laparoscopic Colonic Resection
 Drug: Entereg
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Entereg Laparoscopic Colon Resection Study

Resource links provided by NLM:

Drug Information available for: Alvimopan
U.S. FDA Resources

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • length of stay in days [ Time Frame: 7-10 days s/p discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258569

Contacts
Contact: Kristina Johnson, MD 860-548-7336 KJohnson@ctsurgical.com

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102-5037
Principal Investigator: Kristina Johnson, MD            
Sponsors and Collaborators
Hartford Hospital
Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Kristina Johnson, MD, Hartford Hospital
ClinicalTrials.gov Identifier: NCT01258569     History of Changes
Other Study ID Numbers: JOHN002914HE
Study First Received: December 9, 2010
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:
laparoscopic
colon
resection
Entereg

ClinicalTrials.gov processed this record on June 18, 2013