Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for the treatment of pain. It is currently in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 245 participants. The drug is being studied for its potential role in pain management.
Menthol is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the drug's safety and pharmacokinetics in healthy volunteers for the treatment of pain.
Menthol is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The trials were randomized, double-blind, and active-controlled, with a combined enrollment of 245 participants. The drug is investigational and not yet approved for any use.
Menthol has been studied in two completed Phase 1 trials. NCT02192203 investigated the skin sensitization potential of MFC51123 in 227 healthy volunteers. NCT02201238 compared the pharmacokinetics of topical diclofenac/menthol gels with Voltaren gel and oral diclofenac sodium in 18 healthy volunteers. Both trials were conducted in the United States.
Menthol is associated with the compound identifier MFC51123, as referenced in the clinical trial NCT02192203, which investigated the skin sensitization potential of MFC51123. This suggests that MFC51123 may be a formulation or derivative of menthol being evaluated for pain treatment.