Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

PHASE3CompletedINTERVENTIONAL
Enrollment

1,176

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

Conditions
Osteoarthritis
Interventions
DRUG

Diclofenac Sodium Topical Gel, 1%

Opaque, white gel

DRUG

Voltaren Topical Gel, 1%

Opaque, white gel

DRUG

Vehicle Diclofenac Sodium Topical Gel

Opaque, white gel

Trial Locations (22)

226003

King Georges Medical University, Lucknow

302023

Malpani Multispeciality Hospital, Jaipur

360007

Shree Giriraj Multispeciality Hospital, Rajkot

380016

B. J. Medical College & Hospital, Ahmedabad

380061

GMERS Medical College and Hospital, Ahmedabad

390007

Centre For Knee Surgery, Vadodara

400022

Psm Dept Ltmmc & Ltmg Hospital, Mumbai

403716

Goa Medical College, Goa

411001

Bj Medical College, Pune

440009

Government Medical College, Nagpur

440010

Jasleen Hospital, Nagpur

440019

Lata Mangeshkar Hospital, Nagpur

500003

Sunshine Hospitals, Secunderabad

530002

King George Hospital, Visakhapatnam

560034

St Johns Medical College, Bangalore

570001

Mysore Medical College, Mysore

590010

K L E Societys Jawaharlal Nehry Medical College, Belagavi

625020

Apollo Speciality Hospitals, Madurai

673008

Government Medical College, Calicut, Calicut

380 015

Rathi Orthopedic and Research Centre, Ahmedabad

362 001

Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra, Jūnāgadh

226 003

M V Hospital and Research Centre, Lucknow

Sponsors
All Listed Sponsors
collaborator

Sristek Clinical Research Solutions Limited

INDUSTRY

lead

Amneal Pharmaceuticals, LLC

INDUSTRY