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Menthol

Phase 1

Pain | Small molecule | Pain |GSK plc|Last Updated: Jun 29, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment245
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02201238Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac SodiumPHASE1 COMPLETED 18Oct 1, 2014Nov 21, 2014Jun 29, 20171 United States
NCT02192203A Safety Study to Investigate the Skin Sensitization Potential of MFC51123PHASE1 COMPLETED 227Apr 1, 2014Jul 15, 2014Jun 28, 20171 United States
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Study Endpoints
Primary Endpoints
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac
20 days

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

Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac
20 days

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

AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac
20 days

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

Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac
20 days

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

Skin irritation
At least 23 days but not more than 30 days for induction and challenge phases combined

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.

Secondary Endpoints
Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac
20 days
Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac
20 days
Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac
20 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Diclofenac sodium/menthol gel (in tube)EXPERIMENTAL1% 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)EXPERIMENTAL1% 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 tabletsACTIVE_COMPARATOR50mg diclofenac sodium tablets administered orally, three times daily for three consecutive days with 6h between adjacent doses on the same day
Voltaren gelACTIVE_COMPARATORVoltaren 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 GelEXPERIMENTAL1% diclofenac, 3% menthol
Diclofenac Only GelACTIVE_COMPARATOR1% diclofenac, 0.09% menthol
Menthol Only GelACTIVE_COMPARATOR3% menthol
Placebo Only GelPLACEBO_COMPARATOR0.09% menthol
Interventions
NameTypeDescription
Diclofenac sodiumDRUGDiclofenac sodium
MentholDRUGMenthol
Diclofenac + Menthol GelDRUG1% diclofenac, 3% menthol
Diclofenac Only GelDRUG1% diclofenac, 0.09% menthol
Menthol Only GelDRUG3% menthol
Placebo Only GelDRUG0.09% menthol
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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