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

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ClinicalTrials.gov Identifier: NCT02201238
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Diclofenac sodium Drug: Menthol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : November 21, 2014
Actual Study Completion Date : November 21, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. Adverse event monitoring [ Time Frame: 27 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201238


Locations
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United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02201238     History of Changes
Other Study ID Numbers: 202188
RH02175 ( Other Identifier: GSK )
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Diclofenac
Menthol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents