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

NCT ID: NCT02088411

Last Updated: 2014-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2001-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Wobenzym Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diclofenac

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.

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Wobenzym

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.

Group Type ACTIVE_COMPARATOR

Wobenzym

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Diclofenac

Intervention Type DRUG

Wobenzym

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mucos Pharma GmbH, Oberhaching, Germany

UNKNOWN

Sponsor Role collaborator

Atrium Innovations

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mucos Pharma GmbH & Co

Oberhaching, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MU-699412

Identifier Type: -

Identifier Source: org_study_id

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