Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol
The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years of randomization. Otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization):
If the subject is \< 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed.
If the subject is = 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed.
Colonic procedure results must be known prior to randomization into the study and dispensing study medication
During the two-week screening phase, the subject must have conducted self assessments on = 10 days of 14 day (with 80% compliance on daily IVRS calls) compliance assessment using the telephone data entry system
You may not be if
As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician
Subject reported no stool for 7 consecutive days during the two-week screening phase responsible considers the subject unfit for the study
The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematological, or neurological condition).
Clareo Health | Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
