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NCT02192203 · ClinicalTrials.gov registry record · Phase 1
A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 227
- Enrollment target
NCT02192203 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 227 participants.
The verdict
NCT02192203, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 227 participants
- Enrollment target
Study Summary
This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.
Interventions
- DRUG Diclofenac + Menthol Gel
- DRUG Diclofenac Only Gel
- DRUG Menthol Only Gel
- DRUG Placebo Only Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2014-04-01 |
| Est. Completion | 2014-07-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02192203
The ClinicalTrials.gov registry entry for NCT02192203 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Diclofenac + Menthol Gel is the first listed.
NCT02192203 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02192203 about?
NCT02192203 is a clinical study titled "A Safety Study to Investigate the Skin Sensitization Potential of MFC51123". This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute ...
What is the current status of trial NCT02192203?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 227 participants. The study started on 2014-04-01. Estimated completion is 2014-07-15.
What interventions are being tested in trial NCT02192203?
The interventions under investigation include: Diclofenac + Menthol Gel (DRUG), Diclofenac Only Gel (DRUG), Menthol Only Gel (DRUG), Placebo Only Gel (DRUG).
Who is sponsoring clinical trial NCT02192203?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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