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Completed

NCT Number: NCT02088411

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

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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Key information

Conditions

Wobenzym Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mucos Pharma GmbH & Co

Oberhaching, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac

Drug

Wobenzym

Dietary Supplement

Placebo

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Atrium Innovations

Industry

Collaborators

  • Mucos Pharma GmbH, Oberhaching, Germany

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Mar 17, 2014
Registry last updated
Mar 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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