Clinical trial NCT03172780: A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
Official title: A Randomized, Double Blind, Three-arm, Parallel, Placebocontrolled, Clinical Study to Evaluate the Bioequivalence Using Clinical Endpoint of Diclofenac Sodium Gel, 1% (Mylan Inc.) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc.) in Patients With Osteoarthritis (OA) of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-01
Enrollment: 1220
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.

Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria

Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
* Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
* After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
* After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
* Able to tolerate rescue medication with acetaminophen
* Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

* Pregnancy, lactation
* OA of Kellgren-Lawrence grade 4
* OA pain in the contralateral knee requiring medication (OTC or prescription)
* History of OA of either Hip or Hands
* History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
* History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
* History of Drugs or Alcohol abuse within the previous year
* Symptomatic peripheral vascular disease of the study leg
* Any musculoskeletal condition
* Skin disease at the application site
* Active asthma requiring periodic treatment with systemic steroids
* Known history of positive HIV, hepatitis C virus, or HBsAg
* Uncontrolled hypertension
* History of myocardial infarction, thrombotic events, stroke etc.
* Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).

Primary outcomes:
measure: Mean Change in the Total WOMAC Pain Subscale Score
timeFrame: From baseline to week 4
measure: Change From Baseline in WOMAC Pain Subscale Score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Yashoda Hospital - Malakpet
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Yashoda Hospital -Secunderabad
state: Andhra Pradesh
city: Somajiguda
country: India
facility: Yashoda Hospital -Somajiguda
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Riddhi Medical Nursing Home
state: Gujarat
city: Ahmedabad
country: India
facility: Rathi Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Sanjivani Superspeciality Hospital Pvt. Ltd
state: Gujarat
city: Ahmedabad
country: India
facility: B.J Medical College & Civil Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: GMERS Medical College & Civil Hospital
state: Gujarat
city: Baroda
country: India
facility: SSG Hospital and Medical College
state: Gujarat
city: Himmatnagar
country: India
facility: Medistar Multispeciality Hospital
state: Gujarat
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
state: Gujarat
city: Vadodara
country: India
facility: Anand Multispeciality Hospital
state: Gujarat
city: Vadodara
country: India
facility: Parul Sevashram Hospital
state: Gujarat
city: Mangalore
country: India
facility: Omega Hospital
state: Karnataka
city: Mysore
country: India
facility: Mysore Medical College and Research Institute
state: Karnataka
city: Ernakulam
country: India
facility: Sree Narayana Institute of Medical Science
state: Kerala
city: Mumbai
country: India
facility: Sir J. J. Group of Hospital and Grant Government Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal Medical College & General Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College and Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Jasleen Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Institute of Medical sciences and Lata Mangeshkar
state: Maharashtra
city: Nashik
country: India
facility: Supe Heart and Diabetes Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: BJ medical college & Sassoon General Hospital
state: Maharashtra
city: Pune
country: India
facility: Sancheti Institute for Orthopedics & Rehabilitation
state: Maharashtra
city: Thane
country: India
facility: BhaktiVedanta Hospital and Research Institute
state: Maharashtra
city: Bhubaneshwar
country: India
facility: IMS and SUM Hospital
state: Odisha
city: Chennai
country: India
facility: Govt Stanley Medical College & Hospital
state: Tamil Nadu
city: Lucknow
country: India
facility: M.V. Hospital & Research Centre
state: Uttar Pradesh
city: Lucknow
country: India
facility: Ajanta Research Centre
state: Uttar Pradesh
city: Varanasi
country: India
facility: OM surgical Centre and Maternity Home
state: Uttar Pradesh
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics
state: West Bengal
Study officials:
References: