NCT02201238

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2014

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

July 24, 2014

Last Update Submit

June 28, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (4)

  • AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac

    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

    20 days

  • Cmax of Diclofenac gel in tube/Cmax of 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

    20 days

  • AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of 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

    20 days

  • Cmax of Diclofenac gel in roll-on device/Cmax of 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

    20 days

Secondary Outcomes (29)

  • 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

  • Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac

    20 days

  • Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel

    20 days

  • +24 more secondary outcomes

Study Arms (4)

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

Drug: Diclofenac sodiumDrug: Menthol

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

Drug: Diclofenac sodiumDrug: Menthol

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

Drug: Diclofenac sodium

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

Drug: Diclofenac sodium

Interventions

Diclofenac sodiumDRUG

Diclofenac sodium

Diclofenac sodium tabletsDiclofenac sodium/menthol gel (in roll-on device)Diclofenac sodium/menthol gel (in tube)Voltaren gel
MentholDRUG

Menthol

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants aged 18 to 50 years
  • Body mass index between 19-28 (kg/m2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

DiclofenacMenthol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCyclohexanolsHexanolsFatty AlcoholsAlcoholsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 28, 2014

Study Start

October 1, 2014

Primary Completion

November 21, 2014

Study Completion

November 21, 2014

Last Updated

June 29, 2017

Record last verified: 2017-06

Locations

US(1)