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NCT Number: NCT03172780

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yashoda Hospital - Malakpet, Hyderabad, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Diclofenac Sodium Gel 1%

Drug

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

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Drug

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

Placebo Gel

Drug

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

Primary outcomes

  1. Mean Change in the Total WOMAC Pain Subscale Score

    Time frame: 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.

  2. Change From Baseline in WOMAC Pain Subscale Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mylan Pharmaceuticals Private Limited

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2017
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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