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NCT01962987 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 476
- Enrollment target
NCT01962987: Completed Phase 3 study, sponsored by Actavis.
NCT01962987 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 476 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01962987, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 476 participants
- Enrollment target
Study Summary
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis
Primary Outcome
The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.
Interventions
- OTHER Placebo
- DRUG Diclofenac sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 476 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01962987 record still lists
NCT01962987 is an interventional study that assigns participants to a tested intervention. The registered 476 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01962987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01962987 about?
NCT01962987 is a clinical study titled "A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis". To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis
What is the current status of trial NCT01962987?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 476 participants. The study started on 2013-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01962987?
The interventions under investigation include: Placebo (OTHER), Diclofenac sodium (DRUG).
Who is sponsoring clinical trial NCT01962987?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01962987's enrollment target sits among peer trials
476 808th of 2000 higher than 1,193 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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