Trial document




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  DRKS00003599

Trial Description

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Title

Prospective, multicentric, randomised, double-blind, placebo-controlle trial in a parallel-group-design to demontrate weight reduction with polyglucosamine L112 in addition to the basic programme compared to placebo in patients with overweight or obesity

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Main objective of the clinical study is to proof the efficacy of polyglucosamine L112 as an aid for weight-reduction. The participants of this study, female and male, should be slightly overweight up to obese and should not be seriously ill. But under the condition that they are willing to reduce their weight.
Which has to be discovered first.
The participants have to follow the recommendations of the professional associations (like "DAG" German Association for the Study of Obesity, "DGE" German Nutrition Society).
Additional the participants have to take as recommendet either polyglucosamine L112 tablets or tablets without an active ingredient.
After 24 weeks the programme will be switched from "weight loss" to "keep weight" for another 28 weeks.
The data of both groups will be analised and compared and it should be seen, that the group with polyglucosamine L112 will have more participants which lost five or more per cent of their body weight at the end of the 24 weeks of the study and that they could keep that weight during the second half of the year of the study.

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Brief Summary in Scientific Language

Primary aim of this clinical investigation is to prove the efficacy of poliglucosamine L112, given as an adjunct for weight reduction.
The study participants, female and male, should be slightly overweight up to obese but not seriously ill. The participation is only possible under the assumption that they are willing to lose weight. This will be identified in the first part of the clinical investigation.
The participants have to follow the basic programme of the relevant German associations, the evidence based guideline of DAG, DGE, DGEM and DDG with an daily energy deficit of 500 kcal. Additional they have to take as recommended either polyglucosamine L112 tablets or placebo tablets. After 24 weeks, the “weight reduction” will be switched to “stabilise weight” for another 28 weeks.
The data of both groups will be analysed and together with safty data and tolerability properties compared. The results should show, that the primary endpoint in the group with polyglucosamine should have more participtant and also, that in the same group more participants could keep their reduced weight.

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Organizational Data

  •   DRKS00003599
  •   2012/03/27
  •   [---]*
  •   no
  •   Approved
  •   F-2012-002, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1123-0658 
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Health Condition or Problem studied

  •   overweight BMI 26 - 29.9
  •   E66.00 -  [generalization E66.0: Obesity due to excess calories]
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Interventions/Observational Groups

  •   For 24 weeks a Hypocaloric diet (500 kcal) according to the guidance paper of the concerned peer associations, plus polyglucosamine L112 (formoline L112) tablets; 2 x 2 tablets taken together with the two main meals.
    Beginning with week 25: 2 x 1 tablet taken together with the two main mails
  •   For 24 weeks a Hypocaloric diet (500 kcal) according to the guidance paper of the concerned peer associations, plus placebo tablets; 2 x 2 tablets taken together with two main meals.
    Beginning with week 25: 2 x 1 tablet taken together with the two main meals
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Percentage of the patients with a weight-reduction of at least 5 per cent after 24 weeks, compared with base line

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Secondary Outcome

Reduction of the body-fat compartment after 24 weeks compared to base line;
improvement of the pre-diabetes data after 24 weeks compared to base line.
Stabilisation of the body weight for a following 28 weeks compared to week 24;
reduction of the waist circumferenceof of at least 2 cm after 24 weeks compared to base line;
safety and compatibility during duration of the study of 52 weeks.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • other 
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Recruitment

  •   Planned
  •   2012/04/02
  •   322
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Written consent after information;
overweight or ICD-10 E66.00;
Waist circumference female > 88 cm, male > 102 cm;
age 18 to 65 years; negative pregnancy testing and a correct/effective method of contraception;
physical activity and nutrition according to the clinical investigation plan must be possible;
presentation of ECG and blood sample results;

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Exclusion Criteria

Age < 18, > 65 years respectively;
BMI < 26, > 34.9 respectively;
waist circumference female < 88 cm, male < 102 cm;
pregnant or nursing (lactating) women;
contraindication for a weight reduction:
malignant tumour; Diabetes Typ I and II;
actually increased fasting blood sugar;
chronicinflammatory bowel disease;
condition after intestinal operation;
heart insufficiency;
each other disease/treatment in the opinion of each investigator, which could interfear with the safety, compatibility or performance;
alcoholic, reliance on medication or drug addiction;
abuse of laxantia;
known allergy to crustaceans and other ingredients of the verum or placebo tablets;
longterm intake of medications that reduces intestinal movements;
intake of cortikosteroids;
not allowed comedication;
intake of vitamin K antagonists;
intake of medication which will cause interactions, or the are foreseeable and which can not be taken with a gap of four hours to the study medication;
weight reduction within the last 5 monts;
simultaneous participation in other clinical studies;
Inability to understand the sense and purpose of this clinical study or to comply with or fulfill the conditions of the clinical investigation plan

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Certmedica International GmbH
    • Ms.  Dr. med.  Ingrid  Burkard 
    • Magnolienweg 17
    • 63741  Aschaffenburg
    • Germany
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    • Institut für biologische Chemie und Ernährungswissenschaft Universität Hohenheim (140a)
    • Mr.  Prof. Dr. med.  Hans Konrad  Biesalski 
    • Grabenstr. 30
    • 70599  Stuttgart
    • Germany
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    • Adipositas Zentrum Oberhausen
    • Ms.  Dr.  Annette  Chen-Stute 
    • Düppelstr. 45
    • 46045  Oberhausen
    • 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 planned
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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.