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

June 28, 2017 updated by: GlaxoSmithKline

A Pharmacokinetics Study Comparing Systemic Exposure of Topical Diclofenac/Menthol Gels Versus Voltaren Gel and Oral Diclofenac Sodium in Healthy Volunteers at Steady State

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14202
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Diclofenac sodium/menthol gel (in tube)
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 sodium
Diclofenac sodium
Drug: Menthol
Menthol
EXPERIMENTAL: Diclofenac sodium/menthol gel (in roll-on device)
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 sodium
Diclofenac sodium
Drug: Menthol
Menthol
ACTIVE_COMPARATOR: Diclofenac sodium tablets
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
Diclofenac sodium
ACTIVE_COMPARATOR: Voltaren gel
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
Diclofenac sodium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac
Time Frame: 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
20 days
Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac
Time Frame: 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
20 days
AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac
Time Frame: 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
20 days
Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac
Time Frame: 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
20 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac
Time Frame: 20 days
Ratio of minimum plasma concentration (Cmin) of Diclofenac gel in tube and Cmin 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
Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac
Time Frame: 20 days
Ratio of time to maximum plasma concentration (Tmax) of Diclofenac gel in tube and Tmax 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
Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac
Time Frame: 20 days
Ratio of Cmin of Diclofenac gel in roll-on device and Cmin 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
Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac
Time Frame: 20 days
Ratio of Tmax of Diclofenac gel in roll-on device and Tmax 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 tube/Cmax of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of Cmax of Diclofenac gel in tube and Cmax of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
20 days
Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of Voltaren gel 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 Voltaren gel
20 days
Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of Cmin of Diclofenac gel in tube and Cmin of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
20 days
Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of Cmin of Diclofenac gel in roll-on device and Cmin of Voltaren gel 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 Voltaren gel
20 days
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of AUC48-72 hrs of Diclofenac gel in tube and AUC48-72 hrs of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
20 days
AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of Voltaren gel 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 Voltaren gel
20 days
Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of Tmax of Diclofenac gel in tube and Tmax of Voltaren during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
20 days
Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of Tmax of Diclofenac gel in roll-on device and Tmax of Voltaren 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 Voltaren gel
20 days
Cmax of Menthol in gel/Cmax of Menthol reported in literature
Time Frame: 20 days
Ratio of Cmax of Menthol in tube and Cmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
20 days
Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature
Time Frame: 20 days
Ratio of Cmax of Menthol in roll-on device and Cmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
20 days
Cmin of Menthol in gel/Cmin of Menthol reported in literature
Time Frame: 20 days
Ratio of Cmin of Menthol in tube and Cmin of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
20 days
Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature
Time Frame: 20 days
Ratio of Cmin of Menthol in roll-on device and Cmin of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
20 days
Tmax of Menthol in gel/Tmax of Menthol reported in literature
Time Frame: 20 days
Ratio of Tmax of Menthol in tube and Tmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
20 days
Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature
Time Frame: 20 days
Ratio of Tmax of Menthol in roll-on device and Tmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
20 days
T1/2 of Menthol in gel/T1/2 of Menthol reported in literature
Time Frame: 20 days
Ratio of half time elimination (T1/2) of Menthol in tube and T1/2 of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reporetd in literature
20 days
T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature
Time Frame: 20 days
Ratio of T1/2 of Menthol in roll-on device and T1/2 of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
20 days
AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature
Time Frame: 20 days
Ratio of AUC48-72 hrs of Menthol in gel and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
20 days
AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature
Time Frame: 20 days
Ratio of AUC48-72 hrs of Menthol in roll-on device and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
20 days
AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac
Time Frame: 20 days
Ratio of AUC48-72 hrs of Voltaren gel and AUC48-72 hrs of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac
20 days
Cmax of Voltaren gel/Cmax of oral Diclofenac
Time Frame: 20 days
Ratio of Cmax of Voltaren gel and Cmax of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac
20 days
T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac
Time Frame: 20 days
Ratio of T1/2 of Diclofenac gel in tube and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac
Time Frame: 20 days
Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
20 days
T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of T1/2 of Diclofenac gel in tube and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from gel tube as compared to that from Voltaren gel
20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel
Time Frame: 20 days
Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel
20 days
Adverse event monitoring
Time Frame: 27 days
27 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202188
  • RH02175 (OTHER: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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