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

Primary Purpose

Wobenzym, Osteoarthritis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Diclofenac

Wobenzym

Placebo

About this trial

This is an interventional treatment trial for Wobenzym

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mucos Pharma GmbH & Co

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Diclofenac

Wobenzym

Placebo

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)

Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)

Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)

Paracetamol Consumption

Number of paracetamol tablets consumed during the study by subjects

Indices of systemic inflammation

Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein

Adverse Events

Any complications throughout study.

Full Information

NCT ID

NCT02088411

First Posted

March 13, 2014

Last Updated

March 13, 2014

Sponsor

Atrium Innovations

Collaborators

Mucos Pharma GmbH, Oberhaching, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02088411

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

November 2000 (undefined)

Primary Completion Date

November 2001 (Actual)

Study Completion Date

November 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Atrium Innovations

Collaborators

Mucos Pharma GmbH, Oberhaching, Germany

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wobenzym, Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diclofenac

Arm Type

Active Comparator

Arm 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.

Arm Title

Wobenzym

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Diclofenac

Intervention Type

Dietary Supplement

Intervention Name(s)

Wobenzym

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Lequesne Functional Index

Description

Time Frame