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| Name | Class |
|---|---|
| Mucos Pharma GmbH, Oberhaching, Germany | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug |
| ||
| Wobenzym |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mucos Pharma GmbH & Co | Oberhaching | Germany |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| C023295 | Wobenzym |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Other |
|
| Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C) | Change from baseline to 12 weeks |
| Paracetamol Consumption | Number of paracetamol tablets consumed during the study by subjects | Change from baseline to 12 weeks |
| Indices of systemic inflammation | Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein | Change from baseline to 12 weeks |
| Adverse Events | Any complications throughout study. | Through baseline to 12 weeks |