Last updated: 11/07/2018 12:30:24
Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels with Voltaren Gel and Oral Diclofenac Sodium
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Pharmacokinetics Study Comparing Systemic Exposure of Topical Diclofenac/Menthol Gels Versus Voltaren Gel and Oral Diclofenac Sodium in Healthy Volunteers at Steady State
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac
Timeframe: 20 days
Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac
Timeframe: 20 days
AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac
Timeframe: 20 days
Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac
Timeframe: 20 days
Secondary outcomes:
Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac
Timeframe: 20 days
Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac
Timeframe: 20 days
Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac
Timeframe: 20 days
Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac
Timeframe: 20 days
Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel
Timeframe: 20 days
Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel
Timeframe: 20 days
Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel
Timeframe: 20 days
Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel
Timeframe: 20 days
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel
Timeframe: 20 days
AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel
Timeframe: 20 days
Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel
Timeframe: 20 days
Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel
Timeframe: 20 days
Cmax of Menthol in gel/Cmax of Menthol reported in literature
Timeframe: 20 days
Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature
Timeframe: 20 days
Cmin of Menthol in gel/Cmin of Menthol reported in literature
Timeframe: 20 days
Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature
Timeframe: 20 days
Tmax of Menthol in gel/Tmax of Menthol reported in literature
Timeframe: 20 days
Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature
Timeframe: 20 days
T1/2 of Menthol in gel/T1/2 of Menthol reported in literature
Timeframe: 20 days
T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature
Timeframe: 20 days
AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature
Timeframe: 20 days
AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature
Timeframe: 20 days
AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac
Timeframe: 20 days
Cmax of Voltaren gel/Cmax of oral Diclofenac
Timeframe: 20 days
T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac
Timeframe: 20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac
Timeframe: 20 days
T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel
Timeframe: 20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel
Timeframe: 20 days
Adverse event monitoring
Timeframe: 27 days
Interventions:
Enrollment:
18
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Int. Journal of Clinical Pharmacology and Therapeutics, Volume 55 (2017) - April (368 - 372) https://www.dustri.com/nc/article-response-page.html?artId=14985&doi= [epub]
Medical condition
Pain
Product
diclofenac, diclofenac/levomenthol, levomenthol
Collaborators
Not applicable
Study date(s)
October 2014 to November 2014
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- Participants aged 18 to 50 years
- Body mass index between 19-28 (kg/m2)
- Pregnant or lactating females
- Participants having intolerance or hypersensitivity to study material
Inclusion and exclusion criteria
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 location(s)
Location
GSK Investigational Site
Buffalo, New York, United States, 14202
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-21-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for the study 202188 can be found on the GSK Clinical Study Register.
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