Irritable Bowel Syndrome (IBS)
Conditions
Interventions
Trade Name: Lotronex
Product Name: Lotronex
Product Code: GR68755
Pharmaceutical Form: Tablet
INN or Proposed INN: alosetron
Sponsors
GlaxoSmithKline Research and Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. OR • 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 =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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) • gastrointestinal surgery (exceptions include ?6 months post-surgery appendectomy, cholecystectomy, fundoplication without gas bloat, or hiatal hernia repair; ?3 months post-surgery herniorrhaphy without bowel resection) • gastroparesis • GI malignancy • carcinoid syndrome • amyloidosis • chronic pancreatitis • gastrointestinal adhesions • ischemic colitis • toxic megacolon • impaired intestinal circulation • gastrointestinal perforation • thrombophlebitis or hypercoagulable state • gastrointestinal obstruction and/or stricture • coronary artery disease (CAD) • significant atherosclerosis. • Current evidence of (within the past 6 months): • diverticulitis • ileus • symptomatic cholelithiasis • proctitis. • Current evidence of: • Hemoccult (+) stool. 6. The subject has a BMI of =27. 7. Mental impairment or inability or refusal to follow directions. 8. The subject has current evidence of, or has been treated for a malignancy within the past five years (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected). 9. The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT), AST (SGOT) values >2.5 times the upper limit of normal or alkaline phosphatase or bilirubin values >2.0 times the upper limit of normal. 10. The subject displays renal impairment as evidenced by a serum creatinine value >2.0 mg/dl. 11. The subject has used any medication within the seven days prior to dosing, unless approved by the investigator and GSK personnel. Section 9.1. 12. The subject has used an investigational drug, or participated in an investigational study, within 30 days of the Screening Visit. 13. The subject has a history of drug allergies (including but not limited to hypersensitivity responses to a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether there is a difference in colonic mucosal blood flow determined by Laser Doppler Flowmetry (LDF) in subjects who have taken 6 days BID dosing of 1mg alosetron vs. placebo. ; Secondary Objective: To determine there is a difference in colonic mucosal blood flow determined by Laser Doppler Flowmetry (LDF) between female healthy volunteers and female d-IBS patients. ; Primary end point(s): - Left colon mucosal blood flow determined by LDF. - Rectal mucosal blood flow determined by LDF. - Incidence of adverse events grouped by body system. | — |
Countries
United Kingdom
Outcome results
None listed