Trial document




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  DRKS00000543

Trial Description

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Title

A multicentre, double blind, placebo controlled, dose - finding clinical study for three doses of Antiadipositum X 112 T (Cathine-hydrochloride) vs. placebo in 240 patients with a body mass index (BMI) between 27 kg/m2 and 40 kg/m2

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Antiadipositum X-112 T® was launched more than 30 years ago as an pharmacotherapeutic adjuvant for weight reduction in diet-related obesity.
Now, for the first time the efficacy and safety of the drug will be investigated in large clinical trial with 240 participants. Conditions for participation are a BMI between 30 kg/m² and 40 kg/m² or in the case of having additional diseases (Diabetes mellitus Typ 2 and/or impaired fat metabolism) a BMI between 27 kg/m² and 40 kg/m².
Participants will receive either X-112 T® or an ineffective compound (placebo) that should be taken over a period of 12 to 24 weeks. At the end of the trial participants treated with X-112 T® should reduced their weight by 3kg on average, compared to the placebo group.

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Brief Summary in Scientific Language

The investigational medicinal product Antiadipositum X-112 T® (Active agent: cathin) has been marketed in Germany for more than 30 years. Cathine is a drug with an indirect sympathomimetic effect activating the sympathetic nervous system. In this trial we examine the efficacy and safety of different doses of Antiadipositum X 112 T® in comparison to placebo in the treatment of diet-related obesity in patient with a BMI of 30 to 40 kg/m² or in patient with a BMI of 27 to 40 kg/m² with coexisting risk factors like hyperlipidaemia or type 2 diabetes mellitus. The participants who were treated with X 112, should on average lose 3kg in comparison to the placebo group..

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Organizational Data

  •   DRKS00000543
  •   2010/09/02
  •   [---]*
  •   no
  •   Approved
  •   2708/10 , Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   U1111-1116-7751 
  •   2009-010116-15 
  •   4036050 
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Health Condition or Problem studied

  •   E66.00 -  [generalization E66.0: Obesity due to excess calories]
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Interventions/Observational Groups

  •   16mg Cathine hydrochloride -liquid drops / day will be administered orally over a period of 12-24 weeks
  •   32mg Cathine hydrochloride - liquid drops / day will be administered orally over a period of 12-24 weeks
  •   53mg Cathine hydrochloride -liquid drops / day will be administered orally (over a period of 12-24 weeks
  •   0 mg Cathine hydrochloride (placebo) - liquid drops/ day will be administered orally over a period of 12-24 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Placebo
  •   Treatment
  •   Parallel
  •   IIa
  •   [---]*
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Primary Outcome

Primary criterion is weight reduction in kilogram in the treatment groups (dose groups 1- 3) compared with the placebo group (group 0) after 12 weeks

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Secondary Outcome

• evaluation of tachyphylaxia within the first 12 weeks, and, in case of the consent for a prolongation of the trial under well defined circumstances, within the 24 weeks period of treatment.
• blood pressure effects
• pulse effects
• percentage of patients with weight loss > 5 %
• percentage of patients with weight loss > 10 %
• serum lipids
• serum glucose
• change of waist circumference (WC)
• change of waist-hip ratio (WHR)
• change of body Mass Index (BMI)
• weight reduction in the period of 24 weeks (in case of the consent for a prolongation of the trial under well defined circumstances)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   2010/09/13
  •   Actual
  •   240
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Specific:
• male and female patients, aged 18-65 years
• caucasian origin
• diet-related obesity diagnosed by BMI of 30 to 40 kg/m² or diet-related obesity diagnosed by BMI of 27 to 40 kg/m² in patient with coexisting risk factors like hyperlipidaemia, type 2 diabetes mellitus
• Blood pressure: <100/<160
• Resting pulse rate: <100


General:
• written informed consent given by patient after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
• female subjects of childbearing potential willing to use contraception during the study period or have secondary infertility. A highly effective method of birth control is defined as one that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as like implants, injectables, combined oral contraceptives, some IUDs (intrauterine device), sexual abstinence or vasectomised partner. Female subjects of non childbearing potential i.e. menopause, had hysterectomy, bilateral ovariectomy, tubal ligation or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status can be included

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Exclusion Criteria

Specific:
• organic reasons for obesity, e.g. hypothyroidism
• Bulimia nervosa, Anorexia nervosa and binge eating
• cerebrovascular diseases and any diseases of brain
• pulmonary hypertension
• impaired liver function (laboratory values over 2.5-fold the normal range)
• impaired kidney function:
• COPD (Chronic Obstructive Pulmonary Disease)
• bronchial asthma
• Insomnia
• Ischemic Bowel Disease
• narrow angle glaucoma
• men: prostate diseases with residual urine
• haemorrhagic diathesis
• other severe systemic concomitant diseases (except type 2 diabetes mellitus and /or hyperlipidaemia with a BMI between >27 and 40)
• Cut off limit in patients with coexisting risk factors like hyperlipidaemia and type 2 diabetes mellitus. Fasting glucose: 200mg/dL; HbA1c: 9%; Triglycerides: 800mg/dL
• intake of drugs which increase blood pressure and heart rate e.g drugs against cough, cold and allergies like ephedrine and pseudoephedrine and drugs with a decongestant effect like xylometazoline.
• application of adrenergic amines, concurrent or less than two weeks back application of monoaminooxidase inhibitor (MAO-inhibitor), amantadine as well as central nervous system effective drugs for the treatment of mental diseases (e.g. antidepressants, neuroleptics) or drugs for weight reduction or tryptophane for the treatment of insomnia
• intake of guanethidine
• intake of neuroleptics like phenothiazine and butyrophenone
• known intolerance to Cathine , or other ingredients of the test/reference drug
• high caffeine consumption (6 and more cups coffee/day) or intake of 1.5 L of drinks like Coca Cola light or Red Bull Sugarfree
• Cardiovascular diseases heart valve defect, stable coronary heart disease, tachycardia, peripheral artery occlusive disease, hearth rhythm disturbances, angina pectoris, heart insufficiency: NYHA Classification stage 3 and 4
• neuropsychiatric disorder like Gilles-de-la-Tourette-Syndrom; epilepsy, depression
• endocrine disorder like hyperthyroidism, diabetes type 1; phaeochromocytoma, Cushing’s syndrome

General:
• suspected/confirmed drug/alcohol addiction and abuse
• female patients only: pregnancy or lactation, insufficient contraception
• unstable psychic construction which possibly could invalidate given consent
• current or previous participation in another clinical trial within the 12 weeks preceding the start of the study
• concomitant medication or procedures which would interfere with trial medication like adrenergic and psychotropic agents
• therapies in which the sensitivity of the nervous system is altered (e.g. antidepressant therapy, anti-rheumatic therapy)
• patients who are receiving immunosuppressant therapy
• legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
• unreliability or lack of cooperation and compliance
• objection by the investigator to include the patient in the study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • RIEMSER Arzneimittel AG
    • Mr.  Dr.   Berno  Müller 
    • An der Wiek 7
    • 17493   Greifswald- Insel Riems
    • Germany
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    • RIEMSER Arzneimittel AG
    • Mr.  Dr.   Dietmar   Schröder 
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
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    • RIEMSER Arzneimittel AG
    • Mr.  Dr.  Dietmar   Schröder 
    • An der Wiek 7
    • 17493   Greifswald - Insel Riems
    • Germany
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Sources of Monetary or Material Support

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    • RIEMSER Arzneimittel AG
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
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    •   +49 (0)38351 760
    •   +49 (0)38351 778
    •   info at riemser.de
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/05/22
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.