monocentric randomised double-blind pilot trial, double dummy design for comparison of two therapy reginem formoline L112 vs. Orlistat 60 mg in patients with overweight or adipositas - Comparison L112 versus Orlistat
- Conditions
- The product alli and the comparsion product fromoline L112 (medical device) decrease weight by influencing the fat absorption. The effects of both regimes should cause similar results in weight loss.
- Registration Number
- EUCTR2008-001692-30-DE
- Lead Sponsor
- Certmedica International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
overwieghte with BMI >28
diabetes mellitus type 2
body circumference > 80 cm in women or > 94 cm in men
age between 21 or 60 years
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
gravidity or breastfeeding
addiction of alcohol, medicaments or drugs
impossibility to fulfill the criteria of the trial protocol
carcinoma, malignoma
known allergy against crstacea or another ingredient
existing chronic instestinal deseases or obstipation under medical treatment
state after intestinal surgery
treatment with steroid hormones with a dose regimen more than 1 time per day
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method