Who is sponsoring NCT01962987?

NCT01962987 is sponsored by Actavis Inc..

What condition does NCT01962987 study?

NCT01962987 studies Actinic Keratosis.

What drugs are being tested in NCT01962987?

Interventions: Diclofenac sodium, Placebo.

What is the status of NCT01962987?

NCT01962987 is currently COMPLETED.

Last reviewed 2020-07-07 · How we verify

A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Actavis) to Solaraze ® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis

NCT01962987 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Actavis Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	476
Start date	2013-03
Completion	2013-09

Conditions

Actinic Keratosis

Interventions

Diclofenac sodium
Placebo

Primary outcomes

Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90 — 90 days
The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.

Countries

United States