Osteoarthritis, KneePhase 3NCT03172780

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

A Phase 3 study testing Diclofenac sodium gel 1% and Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in people with Osteoarthritis, Knee, run by Mylan Pharmaceuticals Private Limited at 32 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Diclofenac sodium gel 1% and Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,220 participants
Where: 32 sitesIndia
Study dates: 24 May 2017to 5 Dec 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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 locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

India32 sites

Riddhi Medical Nursing Home
Ahmedabad, Gujarat, 380008
Rathi Hospital
Ahmedabad, Gujarat, 380015
Sanjivani Superspeciality Hospital Pvt. Ltd
Ahmedabad, Gujarat, 380015
B.J Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016
GMERS Medical College & Civil Hospital
Ahmedabad, Gujarat, 380061
IMS and SUM Hospital
Bhubaneswar, Odisha, 751003
Govt Stanley Medical College & Hospital
Chennai, Tamil Nadu, 600001
Sree Narayana Institute of Medical Science
Ernākulam, Kerala, 683594
Medistar Multispeciality Hospital
Himmatnagar, Gujarat, 383001
Yashoda Hospital - Malakpet
Hyderabad, Andhra Pradesh, 500036
Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics
Kolkata, West Bengal, 700020
M.V. Hospital & Research Centre
Lucknow, Uttar Pradesh, 226003
Ajanta Research Centre
Lucknow, Uttar Pradesh, 226005
Omega Hospital
Mangalore, Karnataka, 575002
Sir J. J. Group of Hospital and Grant Government Hospital
Mumbai, Maharashtra, 400008
Lokmanya Tilak Municipal Medical College & General Hospital
Mumbai, Maharashtra, 400022
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
Government Medical College and Hospital
Nagpur, Maharashtra, 440003
Jasleen Hospital
Nagpur, Maharashtra, 440012
Institute of Medical sciences and Lata Mangeshkar
Nagpur, Maharashtra, 600001
Supe Heart and Diabetes Hospital & Research Centre
Nashik, Maharashtra, 422002
BJ medical college & Sassoon General Hospital
Pune, Maharashtra, 411001
Sancheti Institute for Orthopedics & Rehabilitation
Pune, Maharashtra, 411005
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005
Yashoda Hospital -Secunderabad
Secunderabad, Andhra Pradesh, 500003
Yashoda Hospital -Somajiguda
Somajiguda, Andhra Pradesh, 500082
BhaktiVedanta Hospital and Research Institute
Thane, Maharashtra, 401107
SSG Hospital and Medical College
Vadodara, Gujarat, 39000
Anand Multispeciality Hospital
Vadodara, Gujarat, 390016
Parul Sevashram Hospital
Vadodara, Gujarat, 391760
OM surgical Centre and Maternity Home
Varanasi, Uttar Pradesh, 221007
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

About this study

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

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
Being tested: Diclofenac sodium gel 1%, Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%, Placebo gel
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03172780
Study group	Role	What they receive
Diclofenac Sodium Gel	Experimental	Diclofenac Sodium Gel, 1% Receives: Drug: Diclofenac sodium gel 1%
Voltaren® Gel	Active comparator	Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% Receives: Drug: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Placebo gel	Placebo comparator	Placebo gel Receives: Drug: Placebo gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 20175 Dec 2017

First posted1 Jun 2017
Study start24 May 2017
Primary completion5 Dec 2017
Study completion5 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03172780
Sponsor's protocol ID: MYL-1601N-3002
Status last verified: Mar 2022
First submitted: 30 May 2017
Last updated: 3 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03172780
Acronym / sponsor ID: MYL-1601N-3002
Conditions: Osteoarthritis, Knee
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,220 participants (actual)
Lead sponsor: Mylan Pharmaceuticals Private LimitedIndustry (pharma, biotech, devices)
Study start: 24 May 2017 (actual)
Primary completion: 5 Dec 2017 (actual)
Study completion: 5 Dec 2017 (actual)
First posted: 1 Jun 2017 (actual)
Results: Posted 20 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Diclofenac Sodium Gel	Experimental	Drug: Diclofenac sodium gel 1%Diclofenac Sodium Gel, 1%
Voltaren® Gel	Active comparator	Drug: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Placebo gel	Placebo comparator	Drug: Placebo gelPlacebo gel

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diclofenac sodium gel 1%Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks	Drug	Diclofenac Sodium Gel
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks	Drug	Voltaren® Gel
Placebo gelVehicle Gel 4 gm, 4 times a day for 4 weeks	Drug	Placebo gel

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 20 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diclofenac Sodium Gel	406	388
Voltaren® Gel	409	389
Placebo Gel	405	389

Primary outcome: Mean Change in the Total WOMAC Pain Subscale Score

Time frame: From baseline to week 4. Mean (Standard Deviation). Unit: score on a scale

Measure	Diclofenac Sodium Gel n = 318	Voltaren® Gel n = 330
Value	-4.3 (2.64)	-4.6 (2.64)

Population analysed: The PP Population was used for analysis of clinical equivalence between Mylan's Diclofenac gel and Voltaren gel. The primary outcome tested in this population was the equivalence of Mylan's Diclofenac sodium gel (1%) verses the Voltaren gel (1%) and thus only Diclofenac Sodium Gel and Voltaren Gel arms are present here. The placebo arm is presented for the superiority analysis.

Primary outcome: Change From Baseline in WOMAC Pain Subscale Score

Time frame: 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Diclofenac Sodium Gel n = 386	Voltaren® Gel n = 402	Placebo Gel n = 396
Value	-4.2 (2.84)	-4.4 (2.74)	-3.2 (3.46)

Population analysed: The mITT Population was used for analysis of superiority of Mylan's Diclofenac gel and Voltaren gel over placebo. The primary outcome tested in this population was the superiority of Mylan's Diclofenac sodium gel (1%) and the Voltaren gel (1%) over placebo and thus all the three arms are presented here.

Adverse events

Time frame: The reporting period for TEAEs started after the informed consent through day 28 after the last application of investigational product, a total of approximately 12 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diclofenac Sodium Gel	0 of 398 (0%)	11 of 398 (2.8%)	0 of 398
Voltaren® Gel	1 of 405 (0.2%)	19 of 405 (4.7%)	1 of 405
Placebo Gel	0 of 400 (0%)	20 of 400 (5%)	0 of 400

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

32 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in the Total WOMAC Pain Subscale Score (time frame: From baseline to week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03172780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.