DICLOFENAC SODIUM

Post-LOE

diclofenac sodium

ANDAOPHTHALMICSOLUTION/DROPS
Approved
Nov 2015
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
19

Mechanism of Action

CLINICAL PHARMACOLOGY Pharmacodynamics Diclofenac sodium is one of a series of phenylacetic acids that has demonstrated anti-inflammatory and analgesic properties in pharmacological studies. It is thought to inhibit the enzyme cyclooxygenase, which is essential in the biosynthesis of…

Clinical Trials (5)

NCT02611804Phase 3Completed

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

Started Oct 2015
492 enrolled
Actinic Keratosis
NCT02290821Phase 3Completed

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries

Started Dec 2014
215 enrolled
Acute Blunt Soft Tissue Injuries/Contusions
NCT02271854Phase 3Completed

A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness

Started Oct 2014
102 enrolled
Muscle Soreness
NCT02201238Phase 1Completed

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium

Started Oct 2014
18 enrolled
Pain
NCT01306318N/ACompleted

A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)

Started Feb 2011
24 enrolled
Healthy Volunteers