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

NCT02088411 | Completed Phase 2 DMC

• 1 other identifier: MU-699412
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Wobenzym; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Indices of systemic inflammation

  Change from baseline to 12 weeks

Study Arms (3)

Diclofenac

ACTIVE COMPARATOR

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

Wobenzym

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

Subjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks.

Other: Placebo

Interventions

Diclofenac DRUG

Diclofenac

Wobenzym DIETARY_SUPPLEMENT

Wobenzym

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atrium Innovations: lead
• Mucos Pharma GmbH, Oberhaching, Germany: collaborator

Study Sites (1)

Mucos Pharma GmbH & Co

Oberhaching, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Diclofenac; Wobenzym

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: November 1, 2000
• Primary Completion: November 1, 2001
• Study Completion: November 1, 2001
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

DE (1)