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Primary objective:
• To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score
Secondary objectives:
This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with osteoarthritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketoprofen | Experimental |
| |
| Diclofenac | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketoprofen topical | Drug | Ketoprofen topical for 21days |
| |
| Diclofenac Topical |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in walking arthritis pain intensity score | Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS) | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in spontaneous arthritis pain intensity score | Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS) | 3 weeks |
| Knee injury and Osteoarthritis Outcome Score (KOOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maksimum Zdorovya | Kemerovo | Russia | ||||
| City Clinical Hospital #1 n.a. Pirogova |
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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 |
|---|---|
| D007660 | Ketoprofen |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
Diclofenac topical for 21days |
|
Mean change in individual parameters and the general normalized Knee injury and Osteoarthritis Outcome Score (KOOS) score (5-point scale)
| 3 weeks |
| Global Impression of Improvement (PGI-I) | Patient Global Impression of Improvement (PGI-I) assessment | 3 weeks |
| Adverse events | frequency, severity, relationship with the study drug | 3 weeks |
| Moscow |
| Russia |
| Rostov State Medical University | Rostov-on-Don | Russia |
| Ryazan State Medical University n.a. I.P.Pavlov | Ryazan | Russia |
| Saratov State Medical University n.a. V.I.Razumovsky | Saratov | Russia |
| Private Healthcare Institution Smolensk Russian Railway Clinical Hospital | Smolensk | Russia |
| Ulyanovsk Regional Clinical Hospital | Ulyanovsk | Russia |
| Regional Clinical Hospital | Vladimir | Russia |
| Clinical Emergency Hospital n.a. N.V.Soloviev | Yaroslavl | Russia |
| D010648 |
| Phenylacetates |