A randomised, placebo-controlled, crossover study to measure the effect of alosetron on mucosal blood flow in female healthy volunteers and diarrhea-predominant IBS subjects - N/A

GlaxoSmithKline Research and Development Limited0 sites0 target enrollmentMarch 3, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 3, 2006

End Date

December 18, 2007

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

GlaxoSmithKline Research and Development Limited

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•1\.The subject signs and dates a written informed consent form prior to the initiation of any study\-related activities.
•2\.The subject is between 18 and 65 years of age at the time of the Screening Visit.
•3\.The subject is female and either:
•A healthy subject.
•Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
•A d\-IBS patient per the Rome II criteria that has a normal result from a flexible sigmoidoscopy or colonoscopy, or flexible sigmoidoscopy plus barium enema, according to subject’s age, within 2 years of the Screening visit.
•If the subject is \<50 years of age, normal result from a flexible sigmoidoscopy or colonoscopy, or flexible sigmoidoscopy plus barium enema.
•If the subject is \=50 years of age, normal result from a colonoscopy or flexible sigmoidoscopy plus barium enema.
•4\.The subject demonstrates a negative urine pregnancy test result prior to investigational product administration and be either:

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1\.The subject is taking oral contraceptive or other hormonal therapy.
•2\.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, hematologic, or neurological condition).
•3\.The subject has constipation\-predominant IBS (c\-IBS) or alternating IBS per the ROME II criteria.
•4\.The subject has current evidence of or history of chronic or severe constipation, or a history of sequelae from constipation.
•5\.Evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but not limited to):
•Current evidence, or history of (at any time in the past):
•inflammatory bowel disease (Crohn's disease or ulcerative colitis)
•celiac disease
•laxative abuse (in the clinical judgement of the physician)