A double−blind, placebo−controlled crossover trial to quantify the effects of sibutramine on energy intake and energy expenditure in obese subjects during a test meal

INTERVENTION: Trade Name: Reductil 10 mg Product Name: Reductil 10 mg Product Code: PL 00037/0326 Pharmaceutical Form: Capsule, hard Other descriptive name: sibutramine hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Reductil 15 mg Product Name: Reductil 15 mg Product Code: PL 00037/0327 Pharmaceutical Form: Capsule, hard Other descriptive name: sibutramine hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Obesity defined as BMI > 30 kg /m2 ; Classification code 10029883 PRIMARY OUTCOME: 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).; Secondary Objective: To relate these effects to pharmacokinetic parameters, and to evaluate effects on energy expenditure and other measures of energy intake. 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