At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 665 enrolled
Drug / intervention
GDC 695 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
In Brief
A Phase 3 clinical trial evaluating GDC 695, Diclofenac Sodium Gel, 3%, and 1 other intervention for Actinic Keratosis. Completed, enrolled 665 participants across 16 sites.
Detailed Summary
This research study is being done to compare the safety and effectiveness of GDC 695 (test drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to establish that these two drugs work better than placebo in the treatment of actinic keratosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedNov 2016
Primary CompletionJul 2017
Study CompletionSep 2017
TodayJul 2026
First PostedNov 2, 2016
Enrollment StartOct 27, 2016
Primary CompletionJul 11, 2017
Study CompletionSep 6, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.7 years ago
Interventions
GDC 695drug
GDC 695 is a topical gel.
Diclofenac Sodium Gel, 3%drug
Diclofenac sodium gel, 3% is an FDA-approved drug.
Vehicle geldrug
Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.