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Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2005-002080-88-GB
Date of registration:	16/08/2005
Prospective Registration:	Yes
Primary sponsor:	Aintree Hospitals NHS Trust and University of Liverpool
Public title:	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 - Sibutramine effects on energy balance in obesity
Scientific title:	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 - Sibutramine effects on energy balance in obesity
Date of first enrolment:	13/09/2005
Target sample size:	36
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002080-88
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): Therapeutic use (Phase IV): yes

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
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Name:
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Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Obesity defined as BMI > 30 kg /m2
Classification code 10029883

Intervention(s)

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

Primary Outcome(s)

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.

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.

Secondary Outcome(s)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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