OsteoarthritisPhase 3NCT02121002
Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
A Phase 3 study testing Diclofenac Sodium Topical Gel, 1% and Voltaren Topical Gel, 1% in people with Osteoarthritis, run by Amneal Pharmaceuticals, LLC at 22 sites in India.
Trial summary
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee. 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 Topical Gel, 1% and Voltaren Topical Gel, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,176 participants
- Where
- 22 sitesIndia
- Study dates
- Apr 2014to Dec 2014
- 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, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
- Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
- After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
- If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
- Able to tolerate rescue medication with paracetamol/acetaminophen.
Who cannot join
- Pregnant or lactating or planning to become pregnant during the study period.
- X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
- History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
- History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
- History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
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- History of gastrointestinal bleeding or peptic ulcer disease.
- Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
- Elevated transaminases at screening.
- Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.
- Concomitant use of corticosteroids or use within 30 days of study randomization.
- Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
- Known allergy to aspirin or nonsteroidal anti-inflammatory drug
- Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
- Receipt of any drug as part of a research study within 30 days prior to screening.
- Previous participation in this study.
- Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
- Recent history of major knee injury or surgery.
- Known history of positive HIV
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
India22 sites
Rathi Orthopedic and Research Centre
Ahmedabad, Gujarat, 380 015
B. J. Medical College & Hospital
Ahmedabad, Gujarat, 380016
GMERS Medical College and Hospital
Ahmedabad, Gujarat, 380061
St Johns Medical College
Bangalore, Karnataka, 560034
K L E Societys Jawaharlal Nehry Medical College
Belagavi, Karnataka, 590010
Government Medical College, Calicut
Calicut, Kerala, 673008
Goa Medical College
Goa, 403716
Malpani Multispeciality Hospital
Jaipur, Rajasthan, 302023
Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra
Jūnāgadh, Gujarat, 362 001
M V Hospital and Research Centre
Lucknow, Uttar Pradesh, 226 003
King Georges Medical University
Lucknow, Uttar Pradesh, 226003
Apollo Speciality Hospitals
Madurai, Tamil Nadu, 625020
Psm Dept Ltmmc & Ltmg Hospital
Mumbai, Maharashtra, 400022
Mysore Medical College
Mysore, Karnataka, 570001
Government Medical College
Nagpur, Maharashtra, 440009
Jasleen Hospital
Nagpur, Maharashtra, 440010
Lata Mangeshkar Hospital
Nagpur, Maharashtra, 440019
Bj Medical College
Pune, Maharashtra, 411001
Shree Giriraj Multispeciality Hospital
Rajkot, Gujurat, 360007
Sunshine Hospitals
Secunderabad, Andhra Pradesh, 500003
Centre For Knee Surgery
Vadodara, Gujarat, 390007
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
About this study
Official title: A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.
- Conditions
- Osteoarthritis
- Being tested
- Diclofenac Sodium Topical Gel, 1%, Voltaren Topical Gel, 1%, Vehicle Diclofenac Sodium Topical Gel
- Keywords
- Knee
- 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 Topical Gel, 1%Drug
Opaque, white gel
Voltaren Topical Gel, 1%Drug
Opaque, white gel
Vehicle Diclofenac Sodium Topical GelDrug
Opaque, white gel
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium Topical Gel, 1% | Experimental | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks Receives: Drug: Diclofenac Sodium Topical Gel, 1% |
| Voltaren Topical Gel, 1% | Active comparator | Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks Receives: Drug: Voltaren Topical Gel, 1% |
| Vehicle Diclofenac Sodium Topical Gel | Placebo comparator | Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks Receives: Drug: Vehicle Diclofenac Sodium Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 4 Weeks in WOMAC Pain Score
Mean change from baseline to week 4 in the Western Ontario McMaster
Osteoarthritis (WOMAC) pain score:
5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
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 posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionDec 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sristek Clinical Research Solutions Limited
- Responsible party
- Sponsor
- Investigators
- Prayag Shah, MD, Study director, Amneal Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121002
- Sponsor's protocol ID
- AM-DCG-001
- Status last verified
- May 2021
- First submitted
- 21 Apr 2014
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02121002
- Acronym / sponsor ID
- AM-DCG-001
- Conditions
- Osteoarthritis
- Keywords
- Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,176 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Sristek Clinical Research Solutions Limited
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Sodium Topical Gel, 1% | Experimental | Drug: Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Voltaren Topical Gel, 1% | Active comparator | Drug: Voltaren Topical Gel, 1%Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Vehicle Diclofenac Sodium Topical Gel | Placebo comparator | Drug: Vehicle Diclofenac Sodium Topical GelVehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
- Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
- After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
- If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
- Able to tolerate rescue medication with paracetamol/acetaminophen.
Key exclusion criteria (19 listed)
- Pregnant or lactating or planning to become pregnant during the study period.
- X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
- History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
- History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
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 Topical Gel, 1%Opaque, white gel | Drug | Diclofenac Sodium Topical Gel, 1% |
| Voltaren Topical Gel, 1%Opaque, white gel | Drug | Voltaren Topical Gel, 1% |
| Vehicle Diclofenac Sodium Topical GelOpaque, white gel | Drug | Vehicle Diclofenac Sodium Topical Gel |
Primary outcome
Change From Baseline to 4 Weeks in WOMAC Pain Score
Time frame: Baseline and Week 4
Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- 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.
Prayag Shah, MD study director
Amneal Pharmaceuticals, LLC
22 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 Topical Gel, 1% and Voltaren Topical Gel, 1% in people with Osteoarthritis, run by Amneal Pharmaceuticals, LLC at 22 sites in India.
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 5 inclusion and 19 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 16 Jun 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?
Change From Baseline to 4 Weeks in WOMAC Pain Score (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 16 Jun 2021.