The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults
NCT ID: NCT02088411
Last Updated: 2014-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2000-11-30
2001-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Diclofenac
Subjects assigned to receive 1 tablet of Diclofenac Sodium (50 mg) and two tablets of an indistinguishable placebo three times daily for a duration of 12 weeks.
Diclofenac
Wobenzym
Subjects assigned to receive 2 tablets of Wobenzym(R) and 1 tablet of an indistinguishable placebo three times daily for a duration of 12 weeks.
Wobenzym
Placebo
Subjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks.
Placebo
Interventions
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Diclofenac
Wobenzym
Placebo
Eligibility Criteria
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Inclusion Criteria
* Lequesne Functional Index score of 10-14
* WOMAC-A pain subscale score greater than or equal to 25
Exclusion Criteria
* 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
40 Years
80 Years
ALL
No
Sponsors
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Mucos Pharma GmbH, Oberhaching, Germany
UNKNOWN
Atrium Innovations
INDUSTRY
Responsible Party
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Locations
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Mucos Pharma GmbH & Co
Oberhaching, , Germany
Countries
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Other Identifiers
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MU-699412
Identifier Type: -
Identifier Source: org_study_id
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