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The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088411
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Collaborator:
Mucos Pharma GmbH, Oberhaching, Germany
Information provided by (Responsible Party):
Atrium Innovations

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wobenzym Osteoarthritis Drug: Diclofenac Dietary Supplement: Wobenzym Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: a Randomized, Double-blind, Placebo-controlled Trial.
Study Start Date : November 2000
Actual Primary Completion Date : November 2001
Actual Study Completion Date : November 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Diclofenac

Arm Intervention/treatment
Active Comparator: 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.
Drug: Diclofenac
Active Comparator: 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.
Dietary Supplement: Wobenzym
Placebo Comparator: Placebo
Subjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks.
Other: Placebo



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A) [ Time Frame: Change from baseline to 12 weeks ]
  2. Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B) [ Time Frame: Change from baseline to 12 weeks ]
  3. Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C) [ Time Frame: Change from baseline to 12 weeks ]
  4. Paracetamol Consumption [ Time Frame: Change from baseline to 12 weeks ]
    Number of paracetamol tablets consumed during the study by subjects

  5. 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

  6. Adverse Events [ Time Frame: Through baseline to 12 weeks ]
    Any complications throughout study.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088411


Locations
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Germany
Mucos Pharma GmbH & Co
Oberhaching, Germany
Sponsors and Collaborators
Atrium Innovations
Mucos Pharma GmbH, Oberhaching, Germany
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Responsible Party: Atrium Innovations
ClinicalTrials.gov Identifier: NCT02088411    
Other Study ID Numbers: MU-699412
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Wobenzym
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors