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Also known as Menthol Only Gel, Menthol Only
Menthol · 2 trials · 1 indication
Ratio of area under the plasma concentration time curve from 48-72 hrs (AUC48-72 hrs) of Diclofenac gel in tube and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
Ratio of maximum plasma concentration (Cmax) of Diclofenac gel in tube and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
During the Induction Phase, the test article and three controls will be applied to adjacent treatment sites on the infrascapular area of the back for nine 48-hour patch applications. Evaluation of dermal reactions at the application sites will be conducted clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation at nine intervals spaced approximately 48-72 hours apart. Following the Induction Phase participants will return to the clinic to begin the Challenge Phase after 12 to 14- day rest phase. The Challenge Phase will consist of one 48-hour patch application to a naive site on the opposite side of the back. Evaluations of dermal reactions at the application sites will be conducted clinically during the Challenge Phase using the same visual scale at 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the challenge patch.
| Arm | Type | Description |
|---|---|---|
| Diclofenac sodium/menthol gel (in tube) | EXPERIMENTAL | 1% diclofenac sodium plus 3% menthol gel (in 30g aluminium tube). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day |
| Diclofenac sodium/menthol gel (in roll-on device) | EXPERIMENTAL | 1% diclofenac sodium plus 3% menthol gel (in roll-on applicator device supplied in 30g plastic bottles). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day |
| Diclofenac sodium tablets | ACTIVE_COMPARATOR | 50mg diclofenac sodium tablets administered orally, three times daily for three consecutive days with 6h between adjacent doses on the same day |
| Voltaren gel | ACTIVE_COMPARATOR | Voltaren gel supplied in 100g aluminium tube. Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day |
| Diclofenac + Menthol Gel | EXPERIMENTAL | 1% diclofenac, 3% menthol |
| Diclofenac Only Gel | ACTIVE_COMPARATOR | 1% diclofenac, 0.09% menthol |
| Menthol Only Gel | ACTIVE_COMPARATOR | 3% menthol |
| Placebo Only Gel | PLACEBO_COMPARATOR | 0.09% menthol |
| Name | Type | Description |
|---|---|---|
| Diclofenac sodium | DRUG | Diclofenac sodium |
| Menthol | DRUG | Menthol |
| Diclofenac + Menthol Gel | DRUG | 1% diclofenac, 3% menthol |
| Diclofenac Only Gel | DRUG | 1% diclofenac, 0.09% menthol |
| Menthol Only Gel | DRUG | 3% menthol |
| Placebo Only Gel | DRUG | 0.09% menthol |
Inclusion Criteria: * Participants aged 18 to 50 years * Body mass index between 19-28 (kg/m2) Exclusion Criteria: * Pregnant or lactating females * Participants having intolerance or hypersensitivity to study material * Participants having positive results for HIV, Hepatitis B or Hepatitis C * P...
Menthol is being developed for pain. It is a small molecule in Phase 1 clinical development, and the completed trials enrolled healthy adult volunteers rather than patients with a specific pain condition. GSK plc, which trades as GSK, is the developer.
Menthol targets TRPM8 and TRPA1. It acts as an opener of these targets, meaning it activates rather than blocks them. TRPM8 is the cold-sensing receptor, which is consistent with the cooling sensation menthol produces when applied topically.
GSK plc, which trades under the ticker GSK, is the developer of Menthol. The company has run the clinical program for the asset, including the two completed Phase 1 studies listed for it.
Menthol is in Phase 1. It is investigational and has not been approved. Two Phase 1 trials are listed, both completed, with no active trials currently reported. Total enrollment across those two studies was 245 participants.
Two completed Phase 1 trials are listed for Menthol. NCT02201238 compared topical diclofenac/menthol gels with Voltaren gel and oral diclofenac sodium in 18 healthy volunteers. NCT02192203 assessed the skin sensitization potential of MFC51123 in 227 healthy volunteers. Both were conducted in the United States.
Yes. Menthol is also known as Menthol Only Gel and Menthol Only, so searches using those names refer to the same asset. It is a small molecule developed by GSK plc for pain and is currently in Phase 1.