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

NCT03172780 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MYL-1601N-3002
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 32

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 weeks

Study Arms (3)

Diclofenac Sodium Gel

EXPERIMENTAL

Diclofenac Sodium Gel, 1%

Drug: Diclofenac sodium gel 1%

Voltaren® Gel

ACTIVE COMPARATOR

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

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

Placebo gel

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo gel

Interventions

Diclofenac sodium gel 1% DRUG

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

Diclofenac Sodium Gel

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% DRUG

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

Voltaren® Gel

Placebo gel DRUG

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

Placebo gel

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mylan Pharmaceuticals Private Limited: lead

Study Sites (32)

Yashoda Hospital - Malakpet

Hyderabad, Andhra Pradesh, 500036, India

Location

Yashoda Hospital -Secunderabad

Secunderabad, Andhra Pradesh, 500003, India

Location

Yashoda Hospital -Somajiguda

Somajiguda, Andhra Pradesh, 500082, India

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Riddhi Medical Nursing Home

Ahmedabad, Gujarat, 380008, India

Location

Rathi Hospital

Ahmedabad, Gujarat, 380015, India

Location

Sanjivani Superspeciality Hospital Pvt. Ltd

Ahmedabad, Gujarat, 380015, India

Location

B.J Medical College & Civil Hospital

Ahmedabad, Gujarat, 380016, India

Location

GMERS Medical College & Civil Hospital

Ahmedabad, Gujarat, 380061, India

Location

Medistar Multispeciality Hospital

Himmatnagar, Gujarat, 383001, India

Location

Shree Giriraj Multispeciality Hospital

Rajkot, Gujarat, 360005, India

Location

SSG Hospital and Medical College

Vadodara, Gujarat, 39000, India

Location

Anand Multispeciality Hospital

Vadodara, Gujarat, 390016, India

Location

Parul Sevashram Hospital

Vadodara, Gujarat, 391760, India

Location

Omega Hospital

Mangalore, Karnataka, 575002, India

Location

Mysore Medical College and Research Institute

Mysore, Karnataka, 570001, India

Location

Sree Narayana Institute of Medical Science

Ernākulam, Kerala, 683594, India

Location

Sir J. J. Group of Hospital and Grant Government Hospital

Mumbai, Maharashtra, 400008, India

Location

Lokmanya Tilak Municipal Medical College & General Hospital

Mumbai, Maharashtra, 400022, India

Location

Government Medical College and Hospital

Nagpur, Maharashtra, 440003, India

Location

Jasleen Hospital

Nagpur, Maharashtra, 440012, India

Location

Institute of Medical sciences and Lata Mangeshkar

Nagpur, Maharashtra, 600001, India

Location

Supe Heart and Diabetes Hospital & Research Centre

Nashik, Maharashtra, 422002, India

Location

BJ medical college & Sassoon General Hospital

Pune, Maharashtra, 411001, India

Location

Sancheti Institute for Orthopedics & Rehabilitation

Pune, Maharashtra, 411005, India

Location

BhaktiVedanta Hospital and Research Institute

Thane, Maharashtra, 401107, India

Location

IMS and SUM Hospital

Bhubaneshwar, Odisha, 751003, India

Location

Govt Stanley Medical College & Hospital

Chennai, Tamil Nadu, 600001, India

Location

M.V. Hospital & Research Centre

Lucknow, Uttar Pradesh, 226003, India

Location

Ajanta Research Centre

Lucknow, Uttar Pradesh, 226005, India

Location

OM surgical Centre and Maternity Home

Varanasi, Uttar Pradesh, 221007, India

Location

Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics

Kolkata, West Bengal, 700020, India

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Prasanna C Ganapathi, Associate Vice President, Global Clinical Sciences
• Organization: Mylan Pharmaceuticals Pvt Ltd.

PrasannaC.Ganapathi@mylan.in

08066728952

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: May 24, 2017
• Primary Completion: December 5, 2017
• Study Completion: December 5, 2017
• Last Updated: March 3, 2022
• Results First Posted: April 20, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (32)