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Voltaren 1% · 1 trial · 1 indication
Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the clinical equivalence of Test Drug (Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD) (Voltaren® Gel 1% of Novartis Consumer Health, Inc.) Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.
Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the superiority of the Test Drug and Reference Listed Drug (RLD) over placebo. Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.
| Arm | Type | Description |
|---|---|---|
| Diclofenac Sodium Gel | EXPERIMENTAL | Diclofenac Sodium Gel, 1% |
| Voltaren® Gel | ACTIVE_COMPARATOR | Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% |
| Placebo gel | PLACEBO_COMPARATOR | Placebo gel |
| Name | Type | Description |
|---|---|---|
| Diclofenac sodium gel 1% | DRUG | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% | DRUG | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Placebo gel | DRUG | Vehicle Gel 4 gm, 4 times a day for 4 weeks |
Inclusion Criteria: * Osteoarthritis knee as per American College of Rheumatology (ACR) criteria * Evidence of OA with Kellgren-Lawrence grade 1-3 disease. * After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee * After discontinuing all pain medicat...
Voltaren 1% is a topical gel used for the treatment of osteoarthritis of the knee. It contains diclofenac sodium, a nonsteroidal anti-inflammatory drug, and is applied directly to the skin over the affected joint to relieve pain and improve function.
Voltaren 1% targets the enzyme cyclooxygenase (COX), which is involved in the production of prostaglandins that cause inflammation and pain. By inhibiting COX, diclofenac sodium reduces inflammation and alleviates pain associated with knee osteoarthritis.
Voltaren 1% is developed by Viatris Inc., a global healthcare company. Viatris is publicly traded on the NASDAQ under the ticker symbol VTRS.
Voltaren 1% is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, but the drug remains in clinical development.
Voltaren 1% has been studied in one Phase 3 clinical trial, identified as NCT03172780. This was a randomized, double-blind, placebo-controlled bioequivalence study with 1,220 participants, conducted in India, to evaluate the efficacy of diclofenac sodium gel 1% in patients with knee osteoarthritis.
Yes, Voltaren 1% is a brand name for diclofenac sodium gel 1%. The active ingredient is diclofenac sodium, and the drug is formulated as a topical gel for the treatment of knee osteoarthritis.