OsteoarthritisPhase 3NCT02596451
To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).
A Phase 3 study testing Diclofenac Sodium gel, 1% and Voltaren® Gel in people with Osteoarthritis, run by Glenmark Pharmaceuticals Ltd. India at 44 sites in United States.
Trial summary
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diclofenac Sodium gel, 1% and Voltaren® Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,164 participants
- Where
- 44 sitesUnited States
- Study dates
- Aug 2015to Mar 2016
- 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
- Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.
- OA Symptoms for at least 6 months prior to screening.
- Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20 point scale for the target knee immediately prior to randomization.
Who cannot join
- History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
- History of gastrointestinal bleeding or peptic ulcer disease.
- Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
- Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Glenmark Investigational Site7
Altoona, Pennsylvania
Glenmark Investigational Site 1
Anaheim, California
Glenmark Investigational Site 21
Anaheim, California
Glenmark Investigational Site 31
Anaheim, California
Glenmark Investigational Site 23
Beaumont, Texas
Glenmark Investigational Site 20
Bryan, Texas
Glenmark Investigational Site 26
Canoga Park, California
Glenmark Investigational Site 42
Carlsbad, California
Glenmark Investigational Site 30
Carmichael, California
Glenmark Investigational Site 33
Cerritos, California
Glenmark Investigational Site 16
Charlottesville, Virginia
Glenmark Investigational Site 34
Dallas, Texas
Glenmark Investigational Site 25
El Cajon, California
Glenmark Investigational Site 9
Englewood, Ohio
Glenmark Investigational Site 8
Evanston, Illinois
Glenmark Investigational Site 10
Fort Lauderdale, Florida
Glenmark Investigational Site 41
Hialeah, Florida
Glenmark Investigational Site 35
Houston, Texas
Glenmark Investigational Site 44
Houston, Texas
Glenmark Investigational Site 36
Knoxville, Tennessee
Glenmark Investigational Site 24
La Mesa, California
Glenmark Investigational Site 4
Lampasas, Texas
Glenmark Investigational Site 5
Mesa, Arizona
Glenmark Investigational Site 15
Miami, Florida
Glenmark Investigational Site 19
Miami, Florida
Glenmark Investigational Site 28
Miami, Florida
Glenmark Investigational Site 32
Miami, Florida
Glenmark Investigational Site 40
Miami, Florida
Glenmark Investigational Site 3
Miami Lakes, Florida
Glenmark Investigational Site12
Midlothian, Virginia
Glenmark Investigational Site 39
Nashville, Tennessee
Glenmark Investigational Site 17
New Orleans, Louisiana
Glenmark Investigational Site 43
Newburgh, Indiana
Glenmark Investigational Site 37
Ormond Beach, Florida
Glenmark Investigational Site 2
Pasadena, California
Glenmark Investigational Site 13
Rancho Cucamonga, California
Glenmark Investigational Site 27
Sacramento, California
Glenmark Investigational Site 22
Saginaw, Michigan
Glenmark Investigational Site 29
San Antonio, Texas
Glenmark Investigational Site 6
San Antonio, Texas
Glenmark Investigational Site 14
St Louis, Missouri
Glenmark Investigational Site 11
West Palm Beach, Florida
Glenmark Investigational Site 18
West Palm Beach, Florida
Glenmark Investigational Site 38
Wichita, Kansas
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee
- Conditions
- Osteoarthritis
- Being tested
- Diclofenac Sodium gel, 1%, Voltaren® Gel, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Sodium gel, 1%Drug
Voltaren® GelDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium gel, 1% | Experimental | apply gel to the target knee Receives: Drug: Diclofenac Sodium gel, 1% |
| Voltaren® Gel | Active comparator | apply gel to the target knee Receives: Drug: Voltaren® Gel |
| Placebo | Placebo comparator | apply gel to the target knee Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
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 OsteoarthritisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahesh V Deshpande, Study director, Glenmark Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596451
- Sponsor's protocol ID
- GLK-1402
- Status last verified
- Jul 2016
- First submitted
- 3 Nov 2015
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee
- ClinicalTrials.gov ID
- NCT02596451
- Acronym / sponsor ID
- GLK-1402
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Sodium gel, 1% | Experimental | Drug: Diclofenac Sodium gel, 1%apply gel to the target knee |
| Voltaren® Gel | Active comparator | Drug: Voltaren® Gelapply gel to the target knee |
| Placebo | Placebo comparator | Drug: Placeboapply gel to the target knee |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.
- OA Symptoms for at least 6 months prior to screening.
- Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20 point scale for the target knee immediately prior to randomization.
Key exclusion criteria (6 listed)
- History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
- History of gastrointestinal bleeding or peptic ulcer disease.
- Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
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% | Drug | Diclofenac Sodium gel, 1% |
| Voltaren® Gel | Drug | Voltaren® Gel |
| Placebo | Drug | Placebo |
Primary outcome
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
Time frame: Baseline and week 4
The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mahesh V Deshpande study director
Glenmark Pharmaceuticals Ltd
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diclofenac Sodium gel, 1% and Voltaren® Gel in people with Osteoarthritis, run by Glenmark Pharmaceuticals Ltd. India at 44 sites in United States.
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 3 inclusion and 6 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. 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 28 Jun 2017). 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?
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2017.