Does irritable bowel syndrome have you feeling irritated?
New research for irritable bowel syndrome

We are looking for people aged 18 to 79 years old, in general good health, who have experienced abdominal pain or discomfort for at least 6 months total during the past 12 months.

The purpose of this study is to compare 4 treatment groups with respect to adequate relief of IBS symptoms. The study drug targets abdominal pain and/or discomfort associated with IBS by acting to enhance a chemical pathway in the body that normalizes disturbed colonic function.

Study Information:

• Duration of the study is 3 to 4 months with 5 study visits; there is also a pre-study visit.
• Investigational study drug in one of three doses or placebo in the following regimens: 0.15 mg study drug twice daily, 0.5 mg study drug twice daily, or 1.0 mg study drug twice daily OR placebo (an inactive substance) twice daily for 12 weeks. Study doses are in tablet form.
• There is a one in three chance of being randomly assigned to the placebo tablet.
• Flexible sigmoidoscopy or colonoscopy (cost covered by the study) may be performed at Screening if the potential study participant has not had one in the past 3 years.
• There is no charge for participation.
• Compensation ($175 total possible) is provided to participants for study-related time and/or travel, based on visits completed. NOTE: There is no compensation for a pre-screen.
• Investigator: John Goff, M.D. of Rocky Mountain Gastroenterology Associates

Entry criteria include the following:

• Male or female, aged 18 to 79
• Females may not be pregnant or breastfeeding, and if of childbearing potential, must be using appropriate birth control prior to enrolling
• Abdominal pain or discomfort must be associated with 2 or more of the following:
• Relieved with defecation;
• Onset associated with a change in frequency of stool; and/or
• Onset associated with a change in form (appearance) of stool
• Must experience at least 3 out of 7 days with at least mild abdominal pain and/or discomfort
• Must normally pass at least one stool per 7-day period

Contact:
Western States Clinical Research, Inc.
Located in:
Wheat Ridge, CO
Telephone: 303-940-0909

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Females with diarrhea-predominant Irritable Bowel Syndrome (IBS)
A 16 week, randomized, placebo-controlled study to assess the Safety of different doses of an investigational medication.

Screening period of 2 weeks
ï Physical examination, blood tests and assessment of IBS.
ï Questionnaires
ï Colonoscopy if not done within 2 years of screening

Baseline
ï Clinical Assessments
ï Start oral medication
ï Start daily self rating of IBS pain/discomfort symptoms

Visit at 4 and 16 weeks
ï Clinical Assessments
ï Blood Sample
ï Start daily self rating of IBS pain/discomfort symptoms

Inclusion Criteria: 18 years or older, female with diagnosis of IBS for at least 6 months and have failed conventional therapy.

Exclusion Criteria: History of constipation, gastroparesis, GI malignancy's, diverticulitis or other Gastrointestinal diseases or conditions. Laxitive abuse. Pregnant or lactating females.

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Multi-Center, Placebo-Controlled study of safety and efficacy for Diarrhea Predominant IBS with a highly specific and selective oral 5-HT3 receptor antagonist.

Screening period up to 28 days
ï Physical examination, blood tests & EKG
ï Questionnaire

Run-In 18 days
ï Daily diary

Treatment period 12 weeks
ï 4 clinic visits
ï Daily diary
ï Study medication 3 times/day

Inclusion:
ï 18 years of age male or female
ï Able to use a touch tone telephone for daily diary
ï Diarrhea-predominant IBS

Exclusion Criteria:
ï Diagnosis of Functional Dyspepsia
ï Pregnant or lactating females
ï Known infection with HIV

Contact:
Gail Danhour, RN
Rocky Mountain Clinical Research, Inc.
29 Rogers Court
Golden, CO 80401
Telephone: 303-279-1550
Fax: 303-278-2602
Email: GailRMCR@aol.com