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

Phase 2

Completed

• Conditions: Wobenzym; Osteoarthritis
• Interventions: Dietary Supplement: Wobenzym; Other: Placebo; Drug: Diclofenac

• Registration Number: NCT02088411
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2001-11
• Study Completion: 2001-11
• Status Verified: 2014-03
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Last Update Submitted: 2014-03-13
• Study First Posted: 2014-03-17
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wobenzym	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.
Placebo	Placebo	Subjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks.
Diclofenac	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.

Primary Outcome Measures

Name	Time	Method
Lequesne Functional Index	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

Name	Time	Method
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	Change from baseline to 12 weeks	Number of paracetamol tablets consumed during the study by subjects
Indices of systemic inflammation	Change from baseline to 12 weeks	Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein
Adverse Events	Through baseline to 12 weeks	Any complications throughout study.

Trial Locations

Locations (1)

Mucos Pharma GmbH & Co; 🇩🇪 Oberhaching, Germany