Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Diclofenac sodium; Drug: Menthol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201238

202188

RH02175 (Other Identifier)

Details and patient eligibility

About

This research study is being conducted to characterize the pharmacokinetic properties of a new topical medication (MFC51123) that contains two active ingredients (diclofenac and menthol) in two formulation packages. One formulation package is in the form of a gel in aluminum tube and the other one in the form of a gel in roll-on applicator bottle. Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol gel has being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains. The rationale for conducting the study is to prove that repeated topical treatment of the new diclofenac + menthol formulation in either of the two packages does not result in unsafe systemic exposure.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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
• Participants having skin lesion at site of application
• Participants having history of alcohol or drug abuse

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

Diclofenac sodium/menthol gel (in tube)

Experimental group

Description:

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

Treatment:

Drug: Menthol

Drug: Diclofenac sodium

Diclofenac sodium/menthol gel (in roll-on device)

Experimental group

Description:

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

Treatment:

Drug: Menthol

Drug: Diclofenac sodium

Diclofenac sodium tablets

Active Comparator group

Description:

50mg diclofenac sodium tablets administered orally, three times daily for three consecutive days with 6h between adjacent doses on the same day

Treatment:

Drug: Diclofenac sodium

Voltaren gel

Active Comparator group

Description:

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

Treatment:

Drug: Diclofenac sodium