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Therapeutic Areas: Gastroenterology | Infections and Infectious Diseases | Family Medicine
Disease Category: Irritable Bowel Syndrome (IBS)
Location: United States, TN

Clinical Trial Details

Overview

Research Study Summary

Treatment of Patients With Irritable Bowel Syndrome With Diarrhea

Purpose

We are currently enrolling for a study to evaluate the safety, tolerability, and efficacy of an investigational drug for patients with Irritable Bowel Syndrome with Diarrhea. This new medication, currently known as 966, is designed to control diarrhea and relieve abdominal discomfort. We are studying the medication at 4 different doses and comparing it to a placebo (an inactive substance, like a sugar pill). If you participate you will be randomly assigned to one of the 4 treatment groups, you will not know what you receive and I will not know what you are taking. The study involves 8 visits to our office on Shallowford Rd over 18 weeks. The first 3-4 weeks will be a screening period to see if you qualify, followed by a 12 week treatment phase and a two week follow-up. Throughout the study you will be asked to report information about your symptoms using a daily phone diary system. There is compensation available to you in the total amount of $400 if you complete all of the visits.

Patient Inclusion Criteria:

  • Must be between the ages of 18 and 65
  • Experience abdominal discomfort related to your bowel habits
  • Have loose or mushy stools most of the time

Patient Exclusion Criteria:

  • Had any GI surgery
  • Had Gallbladder removed
  • Have a history of cancer
  • Have a family history of colon cancer
  • Have Blood in the stool
  • Experience nighttime symptoms of diarrhea
  • Experienced significant weight loss
  • Diagnosed with inflammatory bowel disease, Crohn's disease, ulcerative colitis, diverticulitis, or celiac disease
  • Have uncontrolled blood pressure
  • Had a heart attack or stroke within the past year

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 to 65 Years

Overall Status

Recruiting

Facility Type

N/A

Compensation

Up to $400

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: 170276

Date Last Changed: July 23, 2013


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