Trial Information

A Research Study For Women And Men With Diarrhea Predominant Irritable Bowel Synrome (IBS-D)

We are seeking study volunteers 18-70 years of age who have been diagnosed with IBS-D for at least the last 3 months.

This is a Phase II clinical trial that is being undertaken to evaluate the effects of three doses of an investigational study medication on IBS-D symptoms during 4 weeks of treatment in study volunteers who have diarrhea predominant irritable bowel syndrome (IBS-D). In addition, the three doses of investigational study drug will be compared to placebo (an inactive substance). Safety assessments will also be made during the study.

STUDY INFORMATION:

Study Duration and Visit Information: There are 6 study visits* over approximately 10 weeks. Study volunteers will undergo a screening and run-in process, lasting approximately 4 weeks, during which IBS-D symptoms and other qualifications for this study will be assessed. Those who qualify at the end of the screening and run-in periods will receive one of the four investigational study treatments in a double-blinded manner (neither the study volunteer nor the staff at the research site will know which treatment has been assigned). The treatment period of the study will last 4 weeks. The final study visit will occur two weeks after the end of treatment. *A pre-study visit may also be scheduled.
Study Drug: In patients with diarrhea predominant irritable bowel syndrome (IBS-D), an amino acid that may cause disturbed bowel function appears to be present in higher than normal levels. The investigational study drug acts within the gastrointestinal tract to inhibit the production of this amino acid. Researchers wish to find out if the investigational study drug can safely and effectively relieve the symptoms of IBS-D. In this study, the researchers will evaluate the study drug in a wider population of people suffering from IBS-D than in the previous clinical trials they have carried out in this line of research. The chance of receiving each one of the four different study treatments* is 25%. *3 different doses of study drug or placebo (an inactive substance)
Study Procedures: Procedures for the study include physical exams, laboratory tests, and 12-lead electrocardiograms (ECG’s). Electronic diaries will be dispensed to study participants to record information between visits.
There is no charge for participation. Study medication or placebo, study procedures and study visits are provided at no cost.
Compensation will be provided to qualified participants to help cover study-related time and/or travel.
Principal Investigator: William Elzi, M.D. of Wheat Ridge Internal Medicine

Patient Inclusion Criteria:

Males or females at least 18 and no more than 70 years old
Diagnosed with diarrhea predominant irritable bowel syndrome (IBS-D) for at least the past 3 months, with symptoms starting at least 6 months before the diagnosis
If age 50 or older, must have had a colon evaluation within the past 5 years (air contrast barium enema, virtual colonoscopy or endoscopic colonoscopy), and this evaluation must be available for review
Females or a males capable of producing children* must be willing to use an adequate method of contraception during the study and for 30 days after the follow-up visit
NOTE: Adequate methods of contraception for study participants and their partners include condoms with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), oral contraceptive pill or depoprogesterone injections, and abstinence.
*Otherwise, female study participants should be at least 2 years postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation) and males must have had a vasectomy.
Willing and able to discontinue any current drug treatment for IBS* with the exception of bulking agents during study participation
*Includes antidiarrheal agents such as diphenoxylate (found in Lomotil) or bismuth subsalicylate (found in Pepto Bismol).
NOTE 1: Up to 2 doses of loperamide (i.e., Imodium) per week will be allowed as rescue medication during the study.
NOTE 2: Use of bulking agents such as psyllium products, fiber tablets, etc., with a stable regimen (no significant change in the past 3 months) will be allowed, but should not be discontinued, nor new such agents started, during the study.

NOTE: Additional Inclusion Criteria will be assessed during the screening process.

Patient Exclusion Criteria:

Pregnant or nursing females
History of lactose or gluten intolerance
Currently smoking more than 10 cigarettes per day
Habitually drinking more than six (8 ounce) cups of coffee per day (or an equivalent caffeine-containing beverage)
Currently participating in another clinical research study of any type, OR participation in another clinical research study within the past 30 days, OR participation in a clinical research study for a biologic agent within the past 90 days

Cheri Casey, Mary Reid or Jodi Frazier, Study Coordinators
Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033
Phone: 303-940-0909 (This is a message line; your call will be returned within 24 hours M-F)
Fax: 303-940-0308
Email: research@wscrinc.com

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Research Center Information: Western States Clinical Research, Inc.

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