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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Diclofenac sodium gel 1%
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Placebo gel
Sponsored by
Mylan Pharmaceuticals Private Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Yashoda Hospital - Malakpet
  • Yashoda Hospital -Secunderabad
  • Yashoda Hospital -Somajiguda
  • King George Hospital
  • Riddhi Medical Nursing Home
  • Rathi Hospital
  • Sanjivani Superspeciality Hospital Pvt. Ltd
  • B.J Medical College & Civil Hospital
  • GMERS Medical College & Civil Hospital
  • SSG Hospital and Medical College
  • Medistar Multispeciality Hospital
  • Shree Giriraj Multispeciality Hospital
  • Anand Multispeciality Hospital
  • Parul Sevashram Hospital
  • Omega Hospital
  • Mysore Medical College and Research Institute
  • Sree Narayana Institute of Medical Science
  • Sir J. J. Group of Hospital and Grant Government Hospital
  • Lokmanya Tilak Municipal Medical College & General Hospital
  • Government Medical College and Hospital
  • Jasleen Hospital
  • Institute of Medical sciences and Lata Mangeshkar
  • Supe Heart and Diabetes Hospital & Research Centre
  • BJ medical college & Sassoon General Hospital
  • Sancheti Institute for Orthopedics & Rehabilitation
  • BhaktiVedanta Hospital and Research Institute
  • IMS and SUM Hospital
  • Govt Stanley Medical College & Hospital
  • M.V. Hospital & Research Centre
  • Ajanta Research Centre
  • OM surgical Centre and Maternity Home
  • Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Diclofenac Sodium Gel

Voltaren® Gel

Placebo gel

Arm Description

Diclofenac Sodium Gel, 1%

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Placebo gel

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2017
Last Updated
March 2, 2022
Sponsor
Mylan Pharmaceuticals Private Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03172780
Brief Title
A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
December 5, 2017 (Actual)
Study Completion Date
December 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Pharmaceuticals Private Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac Sodium Gel
Arm Type
Experimental
Arm Description
Diclofenac Sodium Gel, 1%
Arm Title
Voltaren® Gel
Arm Type
Active Comparator
Arm Description
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Arm Title
Placebo gel
Arm Type
Placebo Comparator
Arm Description
Placebo gel
Intervention Type
Drug
Intervention Name(s)
Diclofenac sodium gel 1%
Intervention Description
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Intervention Description
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Intervention Description
Vehicle Gel 4 gm, 4 times a day for 4 weeks
Primary Outcome Measure Information:
Title
Mean Change in the Total WOMAC Pain Subscale Score
Description
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
Title
Change From Baseline in WOMAC Pain Subscale Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Yashoda Hospital - Malakpet
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500036
Country
India
Facility Name
Yashoda Hospital -Secunderabad
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Yashoda Hospital -Somajiguda
City
Somajiguda
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Riddhi Medical Nursing Home
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380008
Country
India
Facility Name
Rathi Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Sanjivani Superspeciality Hospital Pvt. Ltd
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
B.J Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
GMERS Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380061
Country
India
Facility Name
SSG Hospital and Medical College
City
Baroda
State/Province
Gujarat
ZIP/Postal Code
39000
Country
India
Facility Name
Medistar Multispeciality Hospital
City
Himmatnagar
State/Province
Gujarat
ZIP/Postal Code
383001
Country
India
Facility Name
Shree Giriraj Multispeciality Hospital
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360005
Country
India
Facility Name
Anand Multispeciality Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390016
Country
India
Facility Name
Parul Sevashram Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
391760
Country
India
Facility Name
Omega Hospital
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Facility Name
Mysore Medical College and Research Institute
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Sree Narayana Institute of Medical Science
City
Ernakulam
State/Province
Kerala
ZIP/Postal Code
683594
Country
India
Facility Name
Sir J. J. Group of Hospital and Grant Government Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Lokmanya Tilak Municipal Medical College & General Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400022
Country
India
Facility Name
Government Medical College and Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
Jasleen Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Institute of Medical sciences and Lata Mangeshkar
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
600001
Country
India
Facility Name
Supe Heart and Diabetes Hospital & Research Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422002
Country
India
Facility Name
BJ medical college & Sassoon General Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Sancheti Institute for Orthopedics & Rehabilitation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411005
Country
India
Facility Name
BhaktiVedanta Hospital and Research Institute
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Facility Name
IMS and SUM Hospital
City
Bhubaneshwar
State/Province
Odisha
ZIP/Postal Code
751003
Country
India
Facility Name
Govt Stanley Medical College & Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600001
Country
India
Facility Name
M.V. Hospital & Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Ajanta Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226005
Country
India
Facility Name
OM surgical Centre and Maternity Home
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221007
Country
India
Facility Name
Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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