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

Osteoarthritis, Knee Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172780
• Other study ID #: MYL-1601N-3002
• Status: Completed
• Phase: Phase 3
• Start date: May 24, 2017
• Est. completion date: December 5, 2017

Study information

• Verified date: March 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: December 5, 2017
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac sodium gel 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
• Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
• Placebo gel
Vehicle Gel 4 gm, 4 times a day for 4 weeks

Locations

Country	Name	City	State
India	B.J Medical College & Civil Hospital	Ahmedabad	Gujarat
India	GMERS Medical College & Civil Hospital	Ahmedabad	Gujarat
India	Rathi Hospital	Ahmedabad	Gujarat
India	Riddhi Medical Nursing Home	Ahmedabad	Gujarat
India	Sanjivani Superspeciality Hospital Pvt. Ltd	Ahmedabad	Gujarat
India	SSG Hospital and Medical College	Baroda	Gujarat
India	IMS and SUM Hospital	Bhubaneshwar	Odisha
India	Govt Stanley Medical College & Hospital	Chennai	Tamil Nadu
India	Sree Narayana Institute of Medical Science	Ernakulam	Kerala
India	Medistar Multispeciality Hospital	Himmatnagar	Gujarat
India	Yashoda Hospital - Malakpet	Hyderabad	Andhra Pradesh
India	Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics	Kolkata	West Bengal
India	Ajanta Research Centre	Lucknow	Uttar Pradesh
India	M.V. Hospital & Research Centre	Lucknow	Uttar Pradesh
India	Omega Hospital	Mangalore	Karnataka
India	Lokmanya Tilak Municipal Medical College & General Hospital	Mumbai	Maharashtra
India	Sir J. J. Group of Hospital and Grant Government Hospital	Mumbai	Maharashtra
India	Mysore Medical College and Research Institute	Mysore	Karnataka
India	Government Medical College and Hospital	Nagpur	Maharashtra
India	Institute of Medical sciences and Lata Mangeshkar	Nagpur	Maharashtra
India	Jasleen Hospital	Nagpur	Maharashtra
India	Supe Heart and Diabetes Hospital & Research Centre	Nashik	Maharashtra
India	BJ medical college & Sassoon General Hospital	Pune	Maharashtra
India	Sancheti Institute for Orthopedics & Rehabilitation	Pune	Maharashtra
India	Shree Giriraj Multispeciality Hospital	Rajkot	Gujarat
India	Yashoda Hospital -Secunderabad	Secunderabad	Andhra Pradesh
India	Yashoda Hospital -Somajiguda	Somajiguda	Andhra Pradesh
India	BhaktiVedanta Hospital and Research Institute	Thane	Maharashtra
India	Anand Multispeciality Hospital	Vadodara	Gujarat
India	Parul Sevashram Hospital	Vadodara	Gujarat
India	OM surgical Centre and Maternity Home	Varanasi	Uttar Pradesh
India	King George Hospital	Visakhapatnam	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Pharmaceuticals Private Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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