Weight loss MedDRA version: 9.1 Level: LLT Classification code 10047900 Term: Weight loss
Conditions
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2. Age: Aged 18-60 years inclusive. 3. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. 5. Body Weight: The Body Mass Index (BMI) is within the range 25-33 kg/m2 inclusive. 6. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or who have a positive serum pregnancy test. 2. Breast-feeding: Women who are breast–feeding. 3. Disease a) History of gastro-intestinal (GI) disease (e.g. irritable bowel disease, chronic or current diarrhoea, inflamed bowel, steatorrhoea/fat malabsorption, current hemorrhoids, incontinence). b) History of psychological disease. c) History of surgery for weight loss. d) History of organ transplant. 4. Virology: Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). 5. Medications a) Previous Xenical® (orlistat) use within 1 month prior to screening. b) Currently taking medication or supplements that influence intestinal transit time and other stool formation parameters or influences cramping (e.g., Anticholinergics (such as atropine) or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants, opioid analgesics (including loperamide), calcium channel antagonists, clonidine, cisapride, octreotide. Also, any laxative or antidiarrhoeal product). c) Has taken medication including herbal remedies, for weight loss or appetite control within 4 days prior to commencement of the confinement phase. d) Has taken prescription only medications within 14 days prior to the start of the confinement phase. Cyclosporine is specifically contraindicated. Note that oral contraceptives are allowed. e) Has taken over the counter medications within 48 hours prior to the start of the confinement phase, apart from paracetamol and topical medications which are allowed throughout the study. 6. Diet a) Currently dieting or otherwise unable to eat food provided during confinement phase. b) Food allergies/sensitivities c) Has consumed alcohol within 48 hours prior to the start of the confinement phase. 7. Exercise: Heavy physical activity routine (e.g., athletes in training) as the routine would not be maintained during the study. 8. Substance abuse: Current or recent (within one year of screening) alcohol or other substance abuse. 9. Smokers: Current smokers are excluded from participation in this study. Previous smokers should have been abstinent for at least six months. 10. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 11. Clinical Study/Experimental Medication a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b) Previous participation in this study. 12. Personnel: An employee of the sponsor or the study site or members of their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the pharmacologic equivalence of the 27mg chewable orlistat tablet to the 60mg orlistat (alli?) capsule based on a two-sided test (TOST) using logarithmic scale of % fecal fat excreted. The dose scale methodology for evaluation of therapeutic equivalence will also be performed in the analysis of therapeutic equivalence.;Secondary Objective: To assess and compare the frequency and intensity of commonly observed Adverse Events (AEs).;Primary end point(s): Fecal fat content | — |
Countries
United Kingdom
Outcome results
None listed