Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007250

Trial Description

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Title

The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: a Randomized, Double-blind, Placebo-controlled Trial.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial
was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults
with moderate-to-severe osteoarthritis (OA) of the knee.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007250
  •   2015/04/24
  •   2014/03/13
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02088411  (ClinicalTrials.gov)
  •   MU-699412  (Atrium Innovations)
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Health Condition or Problem studied

  •   Wobenzym
  •   Osteoarthritis
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Drug: Diclofenac
  •   Dietary Supplement: Wobenzym
  •   Other: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Lequesne Functional Index; time frame: Change from baseline to 12 weeks; Self-assessment of the affected knee joint by physician interview using the Lequesne Functional Index (providing an estimate of the degree of pain associated with the affected joint, the maximum distance talked, and activities of daily living).

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Secondary Outcome

- Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A); time frame: Change from baseline to 12 weeks
- Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B); time frame: Change from baseline to 12 weeks
- Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C); time frame: Change from baseline to 12 weeks
- Paracetamol Consumption; time frame: Change from baseline to 12 weeks; Number of paracetamol tablets consumed during the study by subjects
- Indices of systemic inflammation; time frame: Change from baseline to 12 weeks; Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein
- Adverse Events; time frame: Through baseline to 12 weeks; Any complications throughout study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2000/11/30
  •   150
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

- Knee osteoarthritis confirmed by radiography or tomography

- Lequesne Functional Index score of 10-14

- WOMAC-A pain subscale score greater than or equal to 25

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Exclusion Criteria

- History of knee trauma

- History of joint infection

- History of joint surgery

- History of intra-articular injection (viscotherapy)

- History of gastrointestinal diseases

- Use of corticosteroids

- Use of COX-II inhibitors

- Use of glucosamine/chondroitin

- Known sensitivity to paracetamol

- Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)

- Known sensitivity to oral enzymes

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Addresses

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    • Atrium Innovations
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    •   [---]*
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    • Mucos Pharma GmbH, Oberhaching, Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2001/11/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.