The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Utah
Sponsor:
Collaborator:
Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):
Ashok K. Tuteja, University of Utah
ClinicalTrials.gov Identifier:
NCT01412372
First received: June 24, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.

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, if positive, will provide preliminary data for a large scale clinical trial.

This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Mesalamine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change from baseline in gastrointestinal symptoms and IBS specific quality of life after an 8 week treatment period [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
This arm will include those who are randomized to the placebo
Drug: Placebo
This is an inactive pill
Other Name: Inactive drug
Experimental: Mesalamine
This arm is for subjects randomized to the study drug, Mesalamine
Drug: Mesalamine
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
Other Name: Lialda

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria

  1. Men and women age 18-75 years
  2. Rome III criteria for IBS
  3. Symptom onset after apparent acute gastroenteritis
  4. Symptoms of 6 months or greater duration
  5. Normal gross appearance of the colonic mucosa other than erythema
  6. Negative markers for celiac disease and inflammatory bowel disease
  7. Normal thyroid function and serum calcium
  8. Stable medication regimens for other medical conditions.

Exclusion Criteria:

  1. Age <18 or >75 years
  2. Previous diagnosis of or history compatible with IBS
  3. Constipation-predominant IBS.
  4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
  5. History of/or presence of malignancy
  6. 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. .
  7. Current evidence of drug or alcohol abuse as judged by the investigator
  8. Allergy to mesalamine or aspirin
  9. Investigator perception of patient's inability to comply with the study protocol
  10. Unstable psychiatric disease
  11. Recent change in gastrointestinal medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412372

Contacts
Contact: Deva P Gundupalli, MS,MPH 801-581-8051 dev.gundupalli@utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Deva P Gundupalli, MS,MPH    801-581-8051    dev.gundupalli@utah.edu   
Principal Investigator: Ashok Tuteja, M.D.         
Sponsors and Collaborators
University of Utah
Shire Human Genetic Therapies, Inc.
Investigators
Principal Investigator: Ashok Tuteja Gastroenterology
  More Information

No publications provided

Responsible Party: Ashok K. Tuteja, Associate professor of medicine, University of Utah
ClinicalTrials.gov Identifier: NCT01412372     History of Changes
Other Study ID Numbers: 39402
Study First Received: June 24, 2011
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Irritable Bowel Syndrome
Diarrhea
Mesalamine
Gastroenteritis
abdominal pain
hypersensitivity

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Disease
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014