Trial | NCT02088411  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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 Started
Nov 30
2000
Primary Completion
Nov 30
2001
Study Completion
Nov 30
2001
Last Update
Mar 17
2014
Estimate

Drug Diclofenac

Dietary Supplement Wobenzym

Other Placebo

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.

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.

Placebo Placebo Comparator

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

Criteria 

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
No Results Posted