PainPhase 1NCT02201238
Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
A Phase 1 study testing Diclofenac sodium and Menthol in people with Pain, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Diclofenac sodium and Menthol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to 21 Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged 18 to 50 years
- Body mass index between 19-28 (kg/m2)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pain
- Being tested
- Diclofenac sodium, Menthol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac sodiumDrug
Diclofenac sodium
MentholDrug
Menthol
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Diclofenac sodium; Drug: 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 Receives: Drug: Diclofenac sodium; Drug: 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 Receives: 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 Receives: Drug: Diclofenac sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 20 days
Secondary outcomes (29)
Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac
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
Measured: 20 days
Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac
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
Measured: 20 days
Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac
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
Measured: 20 days
Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac
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
Measured: 20 days
Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel
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
Measured: 20 days
Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel
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
Measured: 20 days
Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel
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
Measured: 20 days
Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel
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
Measured: 20 days
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel
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
Measured: 20 days
AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel
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
Measured: 20 days
Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel
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
Measured: 20 days
Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel
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
Measured: 20 days
Cmax of Menthol in gel/Cmax of Menthol reported in literature
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
Measured: 20 days
Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature
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
Measured: 20 days
Cmin of Menthol in gel/Cmin of Menthol reported in literature
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
Measured: 20 days
Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature
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
Measured: 20 days
Tmax of Menthol in gel/Tmax of Menthol reported in literature
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
Measured: 20 days
Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature
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
Measured: 20 days
T1/2 of Menthol in gel/T1/2 of Menthol reported in literature
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
Measured: 20 days
T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature
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
Measured: 20 days
AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature
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
Measured: 20 days
AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature
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
Measured: 20 days
AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac
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
Measured: 20 days
Cmax of Voltaren gel/Cmax of oral Diclofenac
Ratio of Cmax of Voltaren gel and Cmax of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac
Measured: 20 days
T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac
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
Measured: 20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac
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
Measured: 20 days
T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel
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
Measured: 20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel
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
Measured: 20 days
Adverse event monitoring
Measured: 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study start1 Oct 2014
- Primary completion21 Nov 2014
- Study completion21 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201238
- Sponsor's protocol ID
- 202188
- Other IDs
- RH02175
- Status last verified
- Jun 2017
- First submitted
- 24 Jul 2014
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02201238
- Acronym / sponsor ID
- 202188
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 21 Nov 2014 (actual)
- Study completion
- 21 Nov 2014 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diclofenac sodium/menthol gel (in tube) | Experimental | Drug: Diclofenac sodium, Drug: Menthol1% 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 |
| Diclofenac sodium/menthol gel (in roll-on device) | Experimental | Drug: Diclofenac sodium, Drug: Menthol1% 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 |
| Diclofenac sodium tablets | Active comparator | Drug: Diclofenac sodium50mg diclofenac sodium tablets administered orally, three times daily for three consecutive days with 6h between adjacent doses on the same day |
| Voltaren gel | Active comparator | Drug: Diclofenac sodiumVoltaren 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants aged 18 to 50 years
- Body mass index between 19-28 (kg/m2)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac sodiumDiclofenac sodium | Drug | Diclofenac sodium tablets, Diclofenac sodium/menthol gel (in roll-on device), Diclofenac sodium/menthol gel (in tube), Voltaren gel |
| MentholMenthol | Drug | Diclofenac sodium/menthol gel (in roll-on device), Diclofenac sodium/menthol gel (in tube) |
Primary outcome
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
29 secondary outcomes
Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac
Time frame: 20 days
Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac
Time frame: 20 days
Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac
Time frame: 20 days
Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac
Time frame: 20 days
Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel
Time frame: 20 days
Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel
Time frame: 20 days
Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel
Time frame: 20 days
Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel
Time frame: 20 days
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel
Time frame: 20 days
AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel
Time frame: 20 days
Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel
Time frame: 20 days
Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel
Time frame: 20 days
Cmax of Menthol in gel/Cmax of Menthol reported in literature
Time frame: 20 days
Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature
Time frame: 20 days
Cmin of Menthol in gel/Cmin of Menthol reported in literature
Time frame: 20 days
Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature
Time frame: 20 days
Tmax of Menthol in gel/Tmax of Menthol reported in literature
Time frame: 20 days
Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature
Time frame: 20 days
T1/2 of Menthol in gel/T1/2 of Menthol reported in literature
Time frame: 20 days
T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature
Time frame: 20 days
AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature
Time frame: 20 days
AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature
Time frame: 20 days
AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac
Time frame: 20 days
Cmax of Voltaren gel/Cmax of oral Diclofenac
Time frame: 20 days
T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac
Time frame: 20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac
Time frame: 20 days
T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel
Time frame: 20 days
T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel
Time frame: 20 days
Adverse event monitoring
Time frame: 27 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Results for the study 202188 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diclofenac sodium and Menthol in people with Pain, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac (time frame: 20 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.