Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Voltaren, 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...
Voltaren 1% is a topical gel used for the treatment of osteoarthritis, specifically osteoarthritis of the knee. It is a small molecule drug being developed by Amneal Pharmaceuticals, Inc. for this musculoskeletal condition.
Voltaren 1% contains diclofenac sodium, a nonsteroidal anti-inflammatory drug. It works by reducing inflammation and pain in the affected joint, which helps manage the symptoms of osteoarthritis of the knee.
Voltaren 1% is being developed by Amneal Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker AMRX. The drug is intended for the treatment of osteoarthritis.
Voltaren 1% is in Phase 3 clinical development. It has completed one Phase 3 trial, and it is not yet approved by the FDA. The drug remains investigational and is still undergoing clinical evaluation.
Voltaren 1% has one completed Phase 3 trial, NCT02121002, which compared a generic diclofenac sodium topical gel, 1% to Voltaren in subjects with osteoarthritis of the knee. The trial enrolled 1176 participants in India and was placebo-controlled and double-blind.
Voltaren 1% is a branded product containing diclofenac sodium as its active ingredient. The clinical trial NCT02121002 compared a generic diclofenac sodium topical gel, 1% to Voltaren, indicating that Voltaren 1% is the reference product for this generic version.