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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

Tracking Information
First Submitted Date  ICMJE July 24, 2014
First Posted Date  ICMJE July 28, 2014
Last Update Posted Date June 29, 2017
Actual Study Start Date  ICMJE October 1, 2014
Actual Primary Completion Date November 21, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02201238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Adverse event monitoring [ Time Frame: 27 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 reporetd in literature
  • 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
  • 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 reporetd in literature
  • 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
  • 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 reporetd in literature
  • 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
  • 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
  • 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
  • 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 reporetd in literature
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Adverse event monitoring [ Time Frame: 27 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Official Title  ICMJE A Pharmacokinetics Study Comparing Systemic Exposure of Topical Diclofenac/Menthol Gels Versus Voltaren Gel and Oral Diclofenac Sodium in Healthy Volunteers at Steady State
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Diclofenac sodium
    Diclofenac sodium
  • Drug: Menthol
    Menthol
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Diclofenac sodium
    • Drug: 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
    Interventions:
    • Drug: Diclofenac sodium
    • Drug: 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
    Intervention: Drug: 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
    Intervention: Drug: Diclofenac sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2014)
40
Actual Study Completion Date  ICMJE November 21, 2014
Actual Primary Completion Date November 21, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02201238
Other Study ID Numbers  ICMJE 202188
RH02175 ( Other Identifier: GSK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP