RESEARCH STUDY FOR CHRONIC CONSTIPATION

Summary: The purpose of this study is to evaluate the effects on bowel function, as well as the safety and tolerability, of three doses of study drug compared to placebo over a 4-week period in study subjects with chronic constipation.
 
We are seeking volunteers 18 to 64 years old and in general good health who have been experiencing symptoms of constipation for at least 6 months.

STUDY INFORMATION:

• Male or female adults 18 to 64 years of age
• Study Visits: There are 5 study visits and one follow-up telephone visit.  The screening and baseline visits (Visits 1 & 2) may occur during a 2 to 6 week period.  After that, Visits 3, 4, & 5 are two weeks apart.  There may be a pre-study visit.
• Study treatment regimens are: one of 3 different doses of study medication or placebo (an inactive treatment).  The chance of receiving placebo is 1 in 4.
• There is no charge for participation (study procedures, study medication, etc. are no-cost).
• Compensation will be provided to participants to help cover study-related time and/or travel.
• Principal Investigator:  John Goff, M.D. of Rocky Mountain Gastroenterology Associates, P.C.
   

INCLUSION CRITERIA:

• Must have experienced symptoms of constipation for at least the last 6 months.
• Females of childbearing potential must be using a highly effective method of birth control.
• Participants who have not had a recent colon evaluation (flexible sigmoidoscopy or colonoscopy) must be willing to undergo such an evaluation (at no charge) as part of the study.

EXCLUSION CRITERIA:

• May not be currently diagnosed with constipation predominant irritable bowel syndrome.
• Abdominal pain and/or discomfort may not be the main complaint or most bothersome symptom.
• Constipation may not be caused by treatment with medications that can affect bowel function, by a condition that may result in a stricture in the colon, by any pelvic floor dysfunction, or by a metabolic or neurologic disturbance.
• Females who are pregnant or lactating may not participate.
• A history of angina, Reynaud’s syndrome, peripheral vascular disease or ischemic colitis are not allowed.
• May not have a history of cancer, unless it was a skin cancer that has been successfully removed or another type of cancer that has been removed completely and did not spread.
• Dosing with stimulant laxatives on a daily basis for more than 4 consecutive weeks within the past 6 months is not allowed.

Please contact our site for further information about this study!
 
CONTACT INFORMATION:
Amber Bretz, Cheri Casey, Jodi Frazier, Dara Stillman
       
        Western States Clinical Research, Inc.
        9201 W. 44th Avenue
        Wheat Ridge, CO 80033
        Telephone: 303-940-0909
        FAX: 303-940-0308
        E-mail: research@wscrinc.com
        Web Site: www.wscrinc.com