E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To examine the effect of betahistine on body weight in obese female subjects |
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E.2.2 | Secondary objectives of the trial |
• To investigate the effect of betahistine in obese female subjects on the following: - Waist circumference; - Other obesity-related risk factors (blood pressure, plasma lipids, hemoglobin A1c [HbA1c], and fasting plasma glucose [FPG]); - Alertness - Sexual behavior. - Appetite and satiety - Safety and tolerability of betahistine • To investigate pharmacokinetic parameters of betahistine in obese female subjects
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed written informed consent; - Female subjects 18 to 50 years of age; - Pre-menopause; - Obese with a BMI > or = 30 kg/m2 to < or = 40 kg/m2; - Has been obese for at least one year prior to screening; - Non-lactating & Non-pregnant |
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E.4 | Principal exclusion criteria |
- Has obesity of known endocrine origin (e.g., Cushing’s disease, Addison’s disease, hypothalamic tumor), genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet Biedl syndrome); - Previous surgical procedures for weight loss; - History of bulimia or evidence of laxative abuse; - Active or past history of cardiovascular or cerebrovascular disease - Type 1 diabetes mellitus; - Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c >8%; - Renal insufficiency defined as a serum creatinine > or = 1.5 mg/dL (133 µmol/L) at screening; - History of asthma, peptic ulcers or HIV; - Chronic use of antihistamines;
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in body weight (in kg and/or % of body weight) from baseline (randomisation) to week 12 achieving > 2.5% and/or > 5% weight loss between baseline and visit 12. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |