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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01412372
Recruitment Status : Recruiting
First Posted : August 9, 2011
Last Update Posted : October 26, 2018
Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):
Ashok K. Tuteja, University of Utah

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Mesalamine Drug: Placebo Phase 3

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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Study Start Date : June 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in gastrointestinal symptoms and IBS specific quality of life after an 8 week treatment period [ Time Frame: Baseline and 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01412372

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Contact: Jaya Vijayan, M.B.B.S.

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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jaya Vijayan, M.B.B.S.   
Principal Investigator: Ashok Tuteja, M.D.         
Sponsors and Collaborators
University of Utah
Shire Human Genetic Therapies, Inc.
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Principal Investigator: Ashok Tuteja Gastroenterology

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Responsible Party: Ashok K. Tuteja, Associate professor of medicine, University of Utah Identifier: NCT01412372     History of Changes
Other Study ID Numbers: 39402
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Keywords provided by Ashok K. Tuteja, University of Utah:
Irritable Bowel Syndrome
abdominal pain

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