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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Wobenzym
• Intervention / Treatment: Other: Placebo; Drug: Diclofenac; Dietary supplement: Wobenzym

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Oberhaching, Germany
    • Mucos Pharma GmbH & Co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lequesne Functional Index	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).	Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)		Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)		Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)		Change from baseline to 12 weeks
Paracetamol Consumption	Number of paracetamol tablets consumed during the study by subjects	Change from baseline to 12 weeks
Indices of systemic inflammation	Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein	Change from baseline to 12 weeks
Adverse Events	Any complications throughout study.	Through baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Atrium Innovations
• Collaborators: Mucos Pharma GmbH, Oberhaching, Germany

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Primary Completion (Actual): November 1, 2001
• Study Completion (Actual): November 1, 2001

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2014
• Last Update Submitted That Met QC Criteria: March 13, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Immunologic Factors; Adjuvants, Immunologic; Diclofenac; Wobenzym
• Other Study ID Numbers: MU-699412