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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088411
• Other study ID #: MU-699412
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2014
• Last updated: March 13, 2014
• Start date: November 2000
• Est. completion date: November 2001

Study information

• Verified date: March 2014
• Source: Atrium Innovations
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2001
• Est. primary completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Wobenzym

Intervention

Drug:
• Diclofenac

Dietary Supplement:
• Wobenzym

Other:
• Placebo

Locations

Country	Name	City	State
Germany	Mucos Pharma GmbH & Co	Oberhaching

Sponsors (2)

Lead Sponsor	Collaborator
Atrium Innovations	Mucos Pharma GmbH, Oberhaching, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)		Change from baseline to 12 weeks	No
Secondary	Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)		Change from baseline to 12 weeks	No
Secondary	Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)		Change from baseline to 12 weeks	No
Secondary	Paracetamol Consumption	Number of paracetamol tablets consumed during the study by subjects	Change from baseline to 12 weeks	No
Secondary	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	No
Secondary	Adverse Events	Any complications throughout study.	Through baseline to 12 weeks	Yes