Trial document




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  DRKS00000342

Trial Description

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Title

Monocentric, randomised, double-blind, placebo-controlled pilot study in double-dummy design in overweight or obese patients
to compare two treatment regimes (Polyglucosamine L112 vs. Orlistat 60 mg).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

As part of the treatment of overweight and obesity, based on a nutritional course, two overweight-treatments should be tested whether they are comparable. On one hand orlistat 60mg, this pharmaceutical product has to be taken three times a day one capsule. On the other hand polyglucosamine L112, this medication should be taken at lunch and supper. In this study, both products are tested whether they are comparable. Both products are influencing the digestion of fat in a different way.
Examined are the weight loss in kg, the reduction of the waist circumference and the fat-mass in your body, as well as the change of parameters measured from your taken blood and your personal feeling during the participation time.
The tablets and capsules are blistered in a so called double-dummy-design. As tablets and capsules looking different, one would see, which active ingredient would be taken. Hence you will receive both forms, and you have to take always both forms together. Also your doctor does not know, whether in the tablet or in the capsule contains the active ingredient or the pacebo. Therefore you will take both forms totally uninfluenced and therefore also the final results could not unintentionally influenced by the doctor.
You will receive for every day a blister with sufficient tablets and capsules to take them three times daily. Therefore the active ingredient could be either in the tablets or in the capsules. Once you follow the instructions beside the medication it is also important, that you change your behaviour and you should increase your activities. Also you should have a look at the total calories at the fat content of your meals. But this will also be trained in team meetings.

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Brief Summary in Scientific Language

Orlistat 60 mg inhibits long lasting specific fat-digestive enzymes (lipases) in the gastro-intestinal tract, with the result that the fats are unchanged excreted, whereas polyglucosamine L112 binds dietary fats and due to these ionic bounds, digested fats are prevented from absorption and this gel matrix is naturally excreted.
Theoretically both of the therapies must come to comparable results.

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Organizational Data

  •   DRKS00000342
  •   2010/02/24
  •   [---]*
  •   no
  •   Approved
  •   FF 17/2008, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

  •   U1111-1113-7485 
  •   2008-001692-30 
  •   4035627 
  •   003/07  (Pilotstudie)
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Health Condition or Problem studied

  •   E66.99 -  [generalization E66.9: Obesity, unspecified]
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Interventions/Observational Groups

  •   Verumgroup polyglucosamine L112;
    Time of treatment: 12 weeks;
    route of application: oral;
    Breakfast:
    1 x 2 placebo-tablets and 1 x 1 placebo-capsule
    Lunch:
    1 x 2 polyglucosamine L112 tablets and 1 x 1 placebo-capsule
    Supper:
    1 x 2 polyglucosamine L112 tablets and 1 x 1 placebo-capsule
  •   Verumgroup Orlistat 60 mg
    Breakfast:
    1 x 2 placebo-tablets and 1 x 1 orlistat 60 m capsule
    Lunch:
    1 x 2 placebo-tablets and 1 x 1 orlistat 60 m capsule
    Supper:
    1 x 2 placebo-tablets and 1 x 1 orlistat 60 m capsule
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   IIIb
  •   [---]*
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Primary Outcome

Weight reduction of 3 to 5 % of the baseline weight
Reduction of the waist circumference of at least 2 cm
Check of the parameters from the first examination:
weekly, week 1 to 12

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Secondary Outcome

Weekly measurement from week 1 to week 12
to compare with the initial medical examination
Bioimpedanceanalysis (BIA) measurement
non-invasive, utilise the different electrical conductivity of bones, organs , muscles and bodyfat
(percent fat content, % fat mass, % lean mass (fat free mass)
Blood pressure measurement: non-invasive blood pressure NIBP Improvement of blood lipid levels
blood samples taken to a laboratory for
total cholesterol, LDL, HDL, TG
CRP sensitive
Proinsulin
Adiponectine
Antioxidative capacity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/03/08
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   60   Years
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Additional Inclusion Criteria

Overweight with a BMI > 28
Women: waist circumference > 80 cm
Men: waist circumference > 94 cm

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Exclusion Criteria

Pregnancy or breast-feeding
Alcohol-, medication- or drugdependency
Unability to fulfil the criteria of the trial protocol
Cancer, malignoma
Known hypersensivity against crustaceans or one of the excipients
Existing chronic, intestinal diseases, like a required treatment because of an constipation
After intestinal surgery
Diabetes mellitus
Chronic malabsorption syndrome
Cholestasis
Concomitant treatment with cyclosporines, warfarin or other anticoagulants
Liver-malfunctions with transaminases two times above ULN and/or
kidney-malfunctions according a cratinine-clearance above 80ml/min/1.73m²
Taken steroidhormones, could be reduced in their effect
Co-medication: concomitant treatment with
- cyclosporines
- warfarin or other oral anticoagulants
- beta-blocker
- neuroleptica and
- antidepressants is an exclusion criteria.

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Addresses

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    • Certmedica International GmbH
    • Magnolienweg 17
    • 63741  Aschaffenburg
    • Germany
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    • Certmedica International GmbH
    • Ms.  Dr. med.  Ingrid  Burkard 
    • Magnolienweg 17
    • 63741  Aschaffenburg
    • Germany
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    • Gemeinschaftspraxis Dr. Stoll
    • Ms.  Annette  Tschepe-Neumann 
    • Frankfurter Straße 50
    • 63303  Dreieich
    • Germany
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Sources of Monetary or Material Support

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    • Certmedica International GmbH
    • Magnolienweg 17
    • 63741  Aschaffenburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/06/10
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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.