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

Atrium Innovations

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis

Wobenzym

Treatments

Other: Placebo

Drug: Diclofenac

Dietary Supplement: Wobenzym

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02088411

MU-699412

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 3 patient groups, including a placebo group

Diclofenac

Active Comparator group

Description:

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.

Treatment:

Drug: Diclofenac

Wobenzym

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Wobenzym

Placebo

Placebo Comparator group

Description:

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