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NCT02611804 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
A Phase 3 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 3
- Development phase
- 492
- Enrollment target
NCT02611804: Completed Phase 3 study, sponsored by Teva Pharmaceuticals USA.
NCT02611804 is a Phase 3 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 492 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02611804, a Phase 3 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 492 participants
- Enrollment target
Study Summary
To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the clinical equivalence and to show that the efficacy of the 2 active formulations is superior to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald scalp.
Interventions
- DRUG Placebo
- DRUG Diclofenac sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 492 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02611804
The ClinicalTrials.gov registry entry for NCT02611804 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 492 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Pharmaceuticals USA, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02611804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02611804 about?
NCT02611804 is a clinical study titled "A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp". To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the clinical equivalence and to show that the efficacy of the 2 active formulations is superior to that of vehicle in treating su...
What is the current status of trial NCT02611804?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 492 participants. The study started on 2015-10. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02611804?
The interventions under investigation include: Placebo (DRUG), Diclofenac sodium (DRUG).
Who is sponsoring clinical trial NCT02611804?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
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