Multi-Center Study Evaluating the Efficacy of Wobenzym(R)N in Treating Knee Osteoarthritis
Summary
The objective of this study is to determine the most effective dose of Wobenzym® N versus placebo at reducing pain severity as measured by the WOMAC pain score in subjects with symptomatic knee osteoarthritis (OA) at 6 weeks of treatment.
Description
Osteoarthritis (OA) is the most common disease of the joints. The main symptom of OA is pain and later followed by stiffness and decreased function of the joints. It is estimated to affect more than 100 million people worldwide, substantially decreasing their quality of their life. Treatment that can relieve the disease symptoms and more particularly the pain level can greatly improve the quality of life and function of patients suffering from OA of weight-bearing joints such as the knee. Wobenzym® N is a fixed compound made of plant and animal enzyme products with the non-enzymatic component rutin recommended for the treatment of musculoskeletal disorders. The Wobenzym® N formulation contains, per tablet: pancreatin 100 mg, trypsin 24 mg and chymotrypsin 1 mg (from pancreas); bromelain 45 mg; papain 60 mg; and rutin 50 mg.
Over 50 clinical studies have been conducted using similar oral proteolytic enzyme preparations-- Wobenzym® and Phlogenzym®-- with consistently positive findings related to rheumatoid arthritis, sprains and strains, reduction of C-reactive protein, sports injuries and joint and muscular pain, as well as OA of the knee. Several comparative studies conducted with Phlogenzym®, an oral enzyme-rutin combination containing bromelain 90 mg, trypsin 48 mg and rutin 100 mg, have proved the product to be effective and safe in the treatment of OA as compared to NSAIDs. [For review, see Leipner, et al. Biodrugs 2001;15(12):779-89.]
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Knee Osteoarthritis
Intervention
Wobenzym® N, Placebo
Location
Institut de Rhumatologie de Montréal
Montreal
Quebec
Canada
H2L 1S6
Status
Not yet recruiting
Source
Atrium Innovations
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00974428
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
Knee Injuries
Injuries to the knee or the knee joint.
Knee Prosthesis
Replacement for a knee joint.
Arthroplasty, Replacement, Knee
Replacement of the knee joint.
Popliteal Cyst
A SYNOVIAL CYST located in the back of the knee, in the popliteal space arising from the semimembranous bursa or the knee joint.
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PubMed Articles
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