Obesity defined as BMI > 30 kg /m2 Classification code 10029883
Conditions
Interventions
Trade Name: Reductil 10 mg
Product Name: Reductil 10 mg
Product Code: PL 00037/0326
Pharmaceutical Form: Capsule, hard
Other descriptive
Sponsors
Aintree Hospitals NHS Trust and University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Obesity with a body mass index (BMI)>30 kg/m2 and less than 40kg /m2 2. Female, otherwise healthy 3. Age 18-60 4. Must be post-menopausal or sterilised or using a reliable form 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. Diabetes 2. Use of other weight loss medication or any drug that might affect body weight or appetite (including anti-depressants, antipsychotics, beta-blockers, corticosteroids) 3. Hyperthyroidism 4. Hypothyroidism (subjects with a normal TSH and free T4, and on a stable dose of thyroxine for at least 3 months may be included) 5. Uncontrolled hypertension (blood pressure >140/90 mmHg) 6. History of ischaemic heart disease or stroke 7. Significant cardiac dysrhythmias 8. Known chronic liver disease 9. Known renal failure 10. Gilles de la Tourette syndrome 11. Known phaeochromocytoma 12. History of seizures or unexplained syncope 13. Pregnancy 14. History of intolerance to sibutramine or any of its constituents 15. Recent major change in body weight (> 3kg loss or gain in preceding month) 16. History of malignancy 17. Presence of any other medical condition that would, in the opinion of the investigator preclude safe participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To relate these effects to pharmacokinetic parameters, and to evaluate effects on energy expenditure and other measures of energy intake.;Main Objective: To evaluate the effects of sibutramine (at two dose levels of 10 and 15 mgs) against placebo control in terms of food intake using a computerized eating monitor.; Primary end point(s): The effect of placebo and sibutramine (at two dose levels of 10 and 15 mgs) on: (i) Resting metabolic rate and postprandial thermogenesis (measured by indirect calorimetry using a ventilated hood system). (ii) On total food intake (energy) during a test meal measured using a Universal Eating Monitor (UEM). | — |
Countries
United Kingdom
Outcome results
None listed