Asimadoline for the Treatment of Post-Operative Ileus

This study has been completed.

Sponsored by:	Tioga Pharmaceuticals
Information provided by:	Tioga Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00443040

Purpose

The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.

Condition	Intervention	Phase
Post-Operative Ileus	Drug: Asimadoline	Phase II

Drug Information available for: Asimadoline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Asimadoline on the Duration of POI in Subjects Undergoing Laparoscopic/Hand-Assisted Lap Segmental Colonic Resection Secondary to Colon Cancer, Polypectomy or Diverticulitis

Further study details as provided by Tioga Pharmaceuticals:

Estimated Enrollment:	114
Study Start Date:	January 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged 18-80
Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy
Must sign an ICF
Females of childbearing potential must have a negative pregnancy test at screening

Exclusion Criteria:

Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data
Pregnant or breastfeeding females
Use of investigational drugs in previous 30 days
Refusal to discontinue prohibited concomitant medications
Chronic use of prescription narcotics over the previous 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443040

Locations

United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106-5047
United States, Pennsylvania
Marks Colorectal Surgical Associates
Wynnewood, Pennsylvania, United States, 19096

Sponsors and Collaborators

Tioga Pharmaceuticals

More Information

Responsible Party:	Tioga Pharmaceuticals ( J Bornstein )
Study ID Numbers:	ASMP2004
Study First Received:	February 27, 2007
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00443040
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Intestinal Obstruction
Diverticulitis
Ileus
Digestive System Diseases

Gastrointestinal Diseases
Neoplasm Metastasis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009