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Also known as 1% Diclofenac Sodium
1% Diclofenac · 2 trials · 1 indication
AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing.
Cumulative irritation scores will be defined daily as the sum of irritation score and grade number
Adverse events will be graded on a three-point scale: 1. Mild-easily tolerated, causing minimal discomfort and not interfering with normal everyday activities; 2. Moderate-sufficiently discomforting to interfere with normal everyday activities; 3. Severe-any event that prevents normal everyday activities
| Arm | Type | Description |
|---|---|---|
| 1% diclofenac sodium plus 3% menthol | EXPERIMENTAL | 1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| 1% diclofenac sodium plus 0.09% menthol | EXPERIMENTAL | 1% diclofenac sodium plus 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| 3% menthol | EXPERIMENTAL | 3% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| Placebo with 0.09% menthol gel | PLACEBO_COMPARATOR | Placebo with 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| Diclofenac Sodium/Menthol Gel | EXPERIMENTAL | 1% diclofenac sodium + 3% menthol |
| Diclofenac Gel | ACTIVE_COMPARATOR | 1% diclofenac sodium + 0.09% menthol |
| Menthol Gel | ACTIVE_COMPARATOR | 3% menthol |
| Placebo Gel | PLACEBO_COMPARATOR | 0.09% menthol |
| Voltaren Gel | ACTIVE_COMPARATOR | 1% diclofenac sodium |
| Sodium lauryl sulfate | PLACEBO_COMPARATOR | 0.2% Sodium lauryl sulfate |
| Saline | PLACEBO_COMPARATOR | 0.9% saline |
| Name | Type | Description |
|---|---|---|
| 1% diclofenac sodium plus 3% menthol | DRUG | To be applied four times daily for 10 days. |
| 1% diclofenac sodium plus 0.09% menthol | DRUG | To be applied four times daily for 10 days. |
| 3% menthol | DRUG | To be applied four times daily for 10 days. |
| Placebo with 0.09% menthol gel | DRUG | To be applied four times daily for 10 days. |
| 1% Diclofenac Sodium | DRUG | 1% diclofenac sodium |
| 0.09% Menthol | DRUG | 0.09% Menthol |
| 0.2% Sodium Lauryl Sulfate | DRUG | 0.2% Sodium Lauryl Sulfate |
| 0.9% Saline | DRUG | 0.9% Saline |
Inclusion Criteria: * Age: 16-65 years * Good general and mental health * Grade I or Grade II acute sprain of the lateral ankle within 24 hours of Visit 1, a pain intensity score of the ankle sprain that is ≥ 5 as measured on an 11-point numerical rating scale, and a peri-malleolar edema (sub-malle...
1% Diclofenac is a topical pain treatment being developed for pain, including pain from ankle sprain. It is applied to the skin as a gel. GSK plc is developing the product, which has been studied in placebo-controlled trials in adults and adolescents.
1% Diclofenac is being developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical program for the topical diclofenac gel, including a Phase 3 efficacy study in ankle sprain and a Phase 1 skin irritancy study.
1% Diclofenac has reached Phase 3 development. Two trials are listed for the program, both completed, including a Phase 3 multicenter efficacy study and a Phase 1 safety study. No active trials are currently listed for this asset.
1% Diclofenac has been studied in two completed trials. NCT02100670 was a Phase 3 multicenter efficacy study of a diclofenac plus menthol gel in subjects with ankle sprain, enrolling 385 participants in Germany. NCT02169154 was a Phase 1 safety study of skin irritancy potential in 36 healthy volunteers in the United States.