"A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

PHASE3CompletedINTERVENTIONAL
Enrollment

1,220

Participants

Timeline

Start Date

May 24, 2017

Primary Completion Date

December 5, 2017

Study Completion Date

December 5, 2017

Conditions
Osteoarthritis, Knee
Interventions
DRUG

Diclofenac sodium gel 1%

Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

DRUG

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

DRUG

Placebo gel

Vehicle Gel 4 gm, 4 times a day for 4 weeks

Trial Locations (32)

39000

SSG Hospital and Medical College, Vadodara

221007

OM surgical Centre and Maternity Home, Varanasi

226003

M.V. Hospital & Research Centre, Lucknow

226005

Ajanta Research Centre, Lucknow

360005

Shree Giriraj Multispeciality Hospital, Rajkot

380008

Riddhi Medical Nursing Home, Ahmedabad

380015

Rathi Hospital, Ahmedabad

Sanjivani Superspeciality Hospital Pvt. Ltd, Ahmedabad

380016

B.J Medical College & Civil Hospital, Ahmedabad

380061

GMERS Medical College & Civil Hospital, Ahmedabad

383001

Medistar Multispeciality Hospital, Himmatnagar

390016

Anand Multispeciality Hospital, Vadodara

391760

Parul Sevashram Hospital, Vadodara

400008

Sir J. J. Group of Hospital and Grant Government Hospital, Mumbai

400022

Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai

401107

BhaktiVedanta Hospital and Research Institute, Thāne

411001

BJ medical college & Sassoon General Hospital, Pune

411005

Sancheti Institute for Orthopedics & Rehabilitation, Pune

422002

Supe Heart and Diabetes Hospital & Research Centre, Nashik

440003

Government Medical College and Hospital, Nagpur

440012

Jasleen Hospital, Nagpur

500003

Yashoda Hospital -Secunderabad, Secunderabad

500036

Yashoda Hospital - Malakpet, Hyderabad

500082

Yashoda Hospital -Somajiguda, Somajiguda

530002

King George Hospital, Visakhapatnam

570001

Mysore Medical College and Research Institute, Mysore

575002

Omega Hospital, Mangalore

600001

Institute of Medical sciences and Lata Mangeshkar, Nagpur

Govt Stanley Medical College & Hospital, Chennai

683594

Sree Narayana Institute of Medical Science, Ernākulam

700020

Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics, Kolkata

751003

IMS and SUM Hospital, Bhubaneshwar

All Listed Sponsors
lead

Mylan Pharmaceuticals Private Limited

INDUSTRY