Approval Probability
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Adjusted LOA
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Also known as Diclofenac Sodium Topical Gel, 1%
Diclofenac, 1% · 1 trial · 1 indication
Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
| Arm | Type | Description |
|---|---|---|
| Diclofenac Sodium Topical Gel, 1% | EXPERIMENTAL | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Voltaren Topical Gel, 1% | ACTIVE_COMPARATOR | Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Vehicle Diclofenac Sodium Topical Gel | PLACEBO_COMPARATOR | Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks |
| Name | Type | Description |
|---|---|---|
| Diclofenac Sodium Topical Gel, 1% | DRUG | Opaque, white gel |
| Voltaren Topical Gel, 1% | DRUG | Opaque, white gel |
| Vehicle Diclofenac Sodium Topical Gel | DRUG | Opaque, white gel |
Inclusion Criteria: * Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee. * Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease. * After disconti...