Status:
COMPLETED
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Shire Human Genetic Therapies, Inc.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointesti...
Detailed Description
This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men and women age 18-75 years
- Rome III criteria for IBS
- Symptom onset after apparent acute gastroenteritis
- Symptoms of 6 months or greater duration
- Normal gross appearance of the colonic mucosa other than erythema
- Negative markers for celiac disease and inflammatory bowel disease
- Normal thyroid function and serum calcium
- Stable medication regimens for other medical conditions.
Exclusion
- Age \<18 or \>75 years
- Previous diagnosis of or history compatible with IBS
- Constipation-predominant IBS.
- Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
- History of/or presence of malignancy
- Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. .
- Current evidence of drug or alcohol abuse as judged by the investigator
- Allergy to mesalamine or aspirin
- Investigator perception of patient's inability to comply with the study protocol
- Unstable psychiatric disease
- Recent change in gastrointestinal medications
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2019
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01412372
Start Date
June 1 2010
End Date
April 22 2019
Last Update
December 31 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Utah
Salt Lake City, Utah, United States, 84132