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Therapeutic Areas: Gastroenterology
Disease Category: Bowel Dysfunction
Location: United States, TN

Clinical Trial Details

Overview

Research Study Summary

Prevention of Recurrence of Diverticulitis

Purpose

The purpose of this study is to compare 2 doses of study drug (mesalazine) vs placebo for the Prevention of Recurrence of diverticulitis and to study the safety and tolerability of the product as well as evaluate the patient's quality of life. There will be 12 study visits over 96 weeks. Office visits will be scheduled at specific intervals and will include a complete medical history including review of CT scans, colonoscopy results, labs, questionnaires & diary. You will be assigned to one of 3 treatment groups that consist of either 1.5 g mesalazine, 3.0 g mesalazine or placebo for 96 weeks. You will be compensated for your time and travel to participate in the study and all study medications and related procedures are provided at no cost.

Patient Inclusion Criteria:

  • Must be between 30-80 yrs of age
  • Had 3 or more of the following symptoms: left lower quadrant pain, fever, altered bowel habits, nausea
  • Diagnosed with Left sided uncomplicated diverticulitis confirmed by a CT scan
  • Had most recent attack within the last 6 months

Patient Exclusion Criteria:

  • Previous GI surgery except for appendectomy, hemorrhoidectomy, and endoscopic removal of polyps
  • History of colorectal cancer or active colorectal cancer.
  • Active malignancy or treatment with anticancer drugs within the last 5 years
  • Existing or intended pregnancy/breast feeding

To Learn more
Phase

3

Gender

Both Male and Female

Age

30 to 80 Years

Overall Status

Recruiting

Duration

96 Weeks

Facility Type

N/A

Contact

Rhonda Bovine, APN, MSN, CCRP, Clinical Director
ClinSearch, LLC
6035 Shallowford Road Suite 109
Chattanooga, TN 37421
Phone: 423-698-4584
Fax: 423-698-4577

View Map

Research Center Information: ClinSearch, LLC

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 170275

Date Last Changed: July 23, 2013


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