Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule drug in development for the treatment of pain, specifically studied in the context of ankle sprain. It is being developed by GSK plc as a topical gel formulation combined with menthol. The drug is currently in Phase 3 clinical development for pain management.
1% Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting the enzyme cyclooxygenase (COX), which reduces the production of prostaglandins involved in pain and inflammation. When applied topically as a gel, it delivers the active ingredient locally to the site of pain, such as an ankle sprain.
1% Diclofenac is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the efficacy and safety of this topical gel formulation for pain relief.
1% Diclofenac is currently in Phase 3 clinical development for the treatment of pain. It has completed two clinical trials, including a Phase 3 efficacy study and a Phase 1 safety study. The drug is investigational and has not yet been approved by regulatory authorities.
1% Diclofenac has been studied in two completed clinical 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 investigating skin irritancy potential, enrolling 36 healthy volunteers in the United States.
1% Diclofenac is a specific formulation of diclofenac, a well-known NSAID, combined with menthol in a topical gel. While diclofenac gels are available in various strengths and formulations, 1% Diclofenac refers to this particular investigational product being developed by GSK for pain associated with ankle sprain.