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

NCT01412372 | Completed Phase 3 Results DMC

• 1 other identifier: 39402
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Diarrhea; Mesalamine; Gastroenteritis; abdominal pain; hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period

  BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.

  Baseline and 8 weeks

Secondary Outcomes (5)

• Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.

  Baseline and 8 weeks

• Change in Average Bowel Frequency After 8-Week Treatment Period

  Baseline and 8 weeks

• Change in Average Bowel Consistency Score After an 8 Week Treatment Period.

  Baseline and 8 weeks

• Change in Average Abdominal Pain Score After an 8 Week Treatment Period

  Baseline and 8 weeks

• Change in Average Bloating Score After an 8 Week Treatment Period.

  Baseline and 8 weeks

Study Arms (2)

Placebo

EXPERIMENTAL

This arm will include those who are randomized to the placebo

Drug: Placebo

Mesalamine

EXPERIMENTAL

This arm is for subjects randomized to the study drug, Mesalamine

Drug: Mesalamine

Interventions

Mesalamine DRUG

2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo

Also known as: Lialda

Mesalamine

Placebo DRUG

This is an inactive pill

Also known as: Inactive drug

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Shire Human Genetic Therapies, Inc.: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea; Gastroenteritis; Abdominal Pain; Hypersensitivity

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Immune System Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: Dr. Ashok Tuteja
• Organization: University of Utah

Ashok.Tuteja@hsc.utah.edu

801-581-5679

Study Officials

• Ashok Tuteja

  Gastroenterology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of medicine

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: August 9, 2011
• Study Start: June 1, 2010
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Locations

US (1)