Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

This study has been completed.

First Received: March 29, 2007 Last Updated: February 26, 2008 History of Changes

Sponsored by:	Tioga Pharmaceuticals
Information provided by:	Tioga Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00454688

Purpose

The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: Asimadoline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome

Resource links provided by NLM:

Drug Information available for: Asimadoline

U.S. FDA Resources

Further study details as provided by Tioga Pharmaceuticals:

Estimated Enrollment:	600
Study Start Date:	August 2006
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged 18-79
Must sign an ICF
Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
Must demonstrate a willingness to comply with daily telephone diary entry

Exclusion Criteria:

Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
Pregnant or breastfeeding females
Refusal to discontinue prohibited concomitant medications
Use of an investigational drug or participation in an investigational study within 30 days of screening
Inability or unwillingness to use the touch-tone telephone data entry system

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454688

Show 112 Study Locations

Sponsors and Collaborators

Tioga Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	ASMP2003
Study First Received:	March 29, 2007
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00454688 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tioga Pharmaceuticals:

Irritable Bowel Syndrome
Asimadoline

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome

Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on September 10, 2009