A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
- Conditions
- Osteoarthritis, Knee
- Interventions
- Registration Number
- NCT03172780
- Lead Sponsor
- Mylan Pharmaceuticals Private Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1220
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diclofenac Sodium Gel Diclofenac sodium gel 1% Diclofenac Sodium Gel, 1% Placebo gel Placebo gel Placebo gel Voltaren® Gel Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
- Primary Outcome Measures
Name Time Method Change From Baseline in WOMAC Pain Subscale Score 4 weeks Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the superiority of the Test Drug and Reference Listed Drug (RLD) over placebo.
Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome.
'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\].
The timepoints considered for the primary outcomes include baseline and week 4.Mean Change in the Total WOMAC Pain Subscale Score From baseline to week 4 Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the clinical equivalence of Test Drug (Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD) (Voltaren® Gel 1% of Novartis Consumer Health, Inc.) Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome.
'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\].
The timepoints considered for the primary outcomes include baseline and week 4.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
King George Hospital
🇮🇳Visakhapatnam, Andhra Pradesh, India
Sree Narayana Institute of Medical Science
🇮🇳Ernakulam, Kerala, India
Mysore Medical College and Research Institute
🇮🇳Mysore, Karnataka, India
Lokmanya Tilak Municipal Medical College & General Hospital
🇮🇳Mumbai, Maharashtra, India
Government Medical College and Hospital
🇮🇳Nagpur, Maharashtra, India
IMS and SUM Hospital
🇮🇳Bhubaneshwar, Odisha, India
SSG Hospital and Medical College
🇮🇳Baroda, Gujarat, India
Parul Sevashram Hospital
🇮🇳Vadodara, Gujarat, India
BJ medical college & Sassoon General Hospital
🇮🇳Pune, Maharashtra, India
Govt Stanley Medical College & Hospital
🇮🇳Chennai, Tamil Nadu, India
B.J Medical College & Civil Hospital
🇮🇳Ahmedabad, Gujarat, India
Yashoda Hospital -Somajiguda
🇮🇳Somajiguda, Andhra Pradesh, India
Yashoda Hospital - Malakpet
🇮🇳Hyderabad, Andhra Pradesh, India
Riddhi Medical Nursing Home
🇮🇳Ahmedabad, Gujarat, India
Rathi Hospital
🇮🇳Ahmedabad, Gujarat, India
Omega Hospital
🇮🇳Mangalore, Karnataka, India
M.V. Hospital & Research Centre
🇮🇳Lucknow, Uttar Pradesh, India
Ajanta Research Centre
🇮🇳Lucknow, Uttar Pradesh, India
OM surgical Centre and Maternity Home
🇮🇳Varanasi, Uttar Pradesh, India
Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics
🇮🇳Kolkata, West Bengal, India
Yashoda Hospital -Secunderabad
🇮🇳Secunderabad, Andhra Pradesh, India
Medistar Multispeciality Hospital
🇮🇳Himmatnagar, Gujarat, India
Sanjivani Superspeciality Hospital Pvt. Ltd
🇮🇳Ahmedabad, Gujarat, India
GMERS Medical College & Civil Hospital
🇮🇳Ahmedabad, Gujarat, India
Shree Giriraj Multispeciality Hospital
🇮🇳Rajkot, Gujarat, India
Sir J. J. Group of Hospital and Grant Government Hospital
🇮🇳Mumbai, Maharashtra, India
Institute of Medical sciences and Lata Mangeshkar
🇮🇳Nagpur, Maharashtra, India
Supe Heart and Diabetes Hospital & Research Centre
🇮🇳Nashik, Maharashtra, India
BhaktiVedanta Hospital and Research Institute
🇮🇳Thane, Maharashtra, India
Anand Multispeciality Hospital
🇮🇳Vadodara, Gujarat, India
Jasleen Hospital
🇮🇳Nagpur, Maharashtra, India
Sancheti Institute for Orthopedics & Rehabilitation
🇮🇳Pune, Maharashtra, India