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

Mylan Pharmaceuticals Private Limited1,220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,220

Conditions

Osteoarthritis, Knee

Interventions

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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).

Locations (32)

Yashoda Hospital - Malakpet

Hyderabad, Andhra Pradesh, India

Yashoda Hospital -Secunderabad

Secunderabad, Andhra Pradesh, India

Yashoda Hospital -Somajiguda

Somajiguda, Andhra Pradesh, India

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Riddhi Medical Nursing Home

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

Mean Change in the Total WOMAC Pain Subscale Score

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.

Time frame: From baseline to week 4

Change From Baseline in WOMAC Pain Subscale Score

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.

Time frame: 4 weeks