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

• Status: Completed
• Trial end date: 2001-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrium Innovations
• Collaborator: Mucos Pharma GmbH, Oberhaching, Germany
• Treatments: Diclofenac; Wobenzym

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