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

Mylan

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Drug: Diclofenac sodium gel 1%; Drug: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%; Drug: Placebo gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03172780

MYL-1601N-3002

Details and patient eligibility

About

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.

Enrollment: 1,220 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,220 participants in 3 patient groups, including a placebo group

Diclofenac Sodium Gel

Experimental group

Description:

Diclofenac Sodium Gel, 1%

Treatment:

Drug: Diclofenac sodium gel 1%

Voltaren® Gel

Active Comparator group

Description:

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Treatment:

Drug: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Placebo gel

Placebo Comparator group

Description:

Placebo gel

Treatment:

Drug: Placebo gel