Osteoarthritis, KneePhase 3NCT02913521
Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%
A Phase 3 study testing Diclofenac Sodium Gel 1% and Voltaren Gel in people with Osteoarthritis, Knee, run by Akorn, Inc. at 51 sites in 6 countries.
Trial summary
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients 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, Knee
- 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
- 934 participants
- Where
- 51 sitesin 6 countries
- Study dates
- Jun 2015to Jun 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
- Ambulatory male and non-pregnant females 35 years and older diagnosed with osteoarthritis according to the American College of Rheumatology Criteria (ACR) in one knee. Target knee is the one with higher level of pain.
- ACR Criteria includes: Knee Pain and at least 3 of the following: age ≥ 50, stiffness lasting < 30 mins, bony tenderness, crepitus, bony enlargement, and no palpable warmth.
- Symptom onset of > 6 Months prior to Screening for the target knee.
- If female and of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., IUD, oral, transdermal, injected, implanted hormonal contraceptives or condom + spermicide).
- Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).
- Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease based upon the Kellgren-Lawrence disease severity scale.
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- After a minimum of 7-day wash out of all pain medication has Baseline pain on movement score of ≥ 50mm on a 0-100-mm Visual Analogue Scale for the target knee.
- After a minimum of 7-day wash out of all pain medication has Baseline WOMAC Pain sub scale of ≥ 9 on a 5 question, 5 point (0 to 4) Likert scale for the target knee.
- Willing and able to use only acetaminophen as rescue medication.
- Willing and able to comply with the study requirements.
Who cannot join
- Females who are pregnant, breast feeding, or planning a pregnancy.
- Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale.
- History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
- After a minimum of 7-day wash out of all pain medication has Baseline pain on movement score of ≥ 20mm on a 0-100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
- Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) of the knee or rheumatoid arthritis.
- Known history of other chronic inflammatory diseases, (e.g., colitis) or fibromyalgia during last 5 years. Patients whose disease was diagnosed at least 5 (five) years prior to screening visit and have had no known disease activity (i.e., no disease related complaints nor disease treatment prescribed) since then may enter into the study.
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- History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. Patients who have had high blood pressure measured at least 2 (two) years prior to screening visit and have had no disease activity (i.e., no record of hypertension or anti-hypertensive treatment prescribed) for at least 2 (two) years prior to screening visit may enter into the study.
- History of coronary artery bypass graft within 6 months of screening.
- Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max. 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
- Use of warfarin or other anticoagulant therapy within 30 days of screening.
- Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of screening or during the study.
- Known history of gastrointestinal bleeding or peptic ulcer disease.
- Abnormal screening clinical laboratory evaluations which the Investigator deems clinically significant.
- Known allergy to aspirin or NSAIDs.
- Skin lesions or wounds in the affected area.
- Significant (requiring surgery) injury or major knee surgery to either knee within six months prior to screening.
- Transaminase levels that are more than two times the upper limit of the normal range at screening.
- Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the Patient at risk by participating in the study.
- Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
- Receipt of any drug as part of a research study within 30 days prior to screening.
- Previous randomization into this study.
- Known allergy (hypersensitivity) to acetaminophen.
Trial locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
Estonia13 sites
Vee Family Doctor's Center OY
Paide, 72713
OU Mai Perearstid
Pärnu, 85010
East Tallinn Central Hospital
Tallinn, 10138
West Tallinn Central Hospital
Tallinn, 10617
East Tallinn Central Hospital
Tallinn, 11312
Medicum Ltd.
Tallinn, 13619
Linna Health Cerntre
Tallinn
Linnamoisa Perearstikeskus
Tallinn
OU Perearstikeskus Remedium
Tallinn
Pirita Family Doctors Centre
Tallinn
Orthopaedic and Clinical Research Center
Tartu, 50410
Dr.Monika Vask Ltd.
Tartu, 51014
Ltd. Elli Kahar
Tartu
Poland11 sites
CERMED
Bialystok, 15-270
ClinicMed Badurski i Wspolnicy Spolka Jawna
Bialystok, 15-879
St. Luke's hospital in Bielsko-Biala
Bielsko-Biala, 43-300
Private medical practice Jacek Niski
Częstochowa, I04/118
Niepubliczny Zaklad Opieki Zdrowotnej ORTMED sp. z o.o.
Lodz, 91-498
Clinical Best Solutions
Lublin, 20-059
ZOZ w Olawie
Oława, 55-200
MEDICOME Sp. z o.o.
Oświęcim, 32-600
Centrum Medyczne Luxmed, Przezmierowo
Poznan, 60-773
Medical Chamber in Warsaw Nr 5718455
Warsaw, Masovian Voivodeship, 00-341
"REUMA TIKA- Centrnrn Reurnatologii" NZOZ
Warsaw, 02-69 l
Romania9 sites
Spiratul Judetean de Urgenta Bacau
Bacau, 600114
Spital Judetean De Urgenta Bacau
Bacau
Duo Medical
Bucharest, 010584
S.C. lanuli Med Consult Str Intr Lt. Dumitru Lemnea
Bucharest, 010976
Dr Ion Stoia Rheumatology Center
Bucharest, 020983
Emergency County Hospital SF Gheorghe
Bucharest, 520064
RK Medcenter SRL
Iași, 700127
S.C. Clinica Somesan
Mărăști
Ploiești Municipal Hospital
Ploieşti, 100337
Ukraine9 sites
Communal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council"
Cherkasy, 18009
State Institution "Ukrainian State Scientific and Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
Dnipropetrovsk, 49027
State Institution "Professor M.I. Sytenko Institute of Spine and Joint Patholo of the National Academ of Medical Sciences of Ukraine
Kharkiv, 61024
Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"
Kyiv, 04107
State Institution D.F.Chebotariov Institute of Gerontology of NAMS of Ukraine
Kyiv, 04114
State Institution D.F.Chebotariov Institute ofGerontolo!.!v ofNAMS of Ukraine - Dept of Age related changes to Muscoskeletal system
Kyiv, 04114
Communal Institution of.Lviv Regional Council "Yu. Lypa Lviv Regional Hospital of Disabled War Veterans and Former Political Prisoners"
Lviv, 79495
Odesa Regional Clinical Hospital
Odesa, 65025
MI Pyogrov Vinnystya Regional Clinical Hospital
Vinnytsia, 21018
Lithuania5 sites
InMedica
Kaunas, LT-48259
JSC Vita Longa
Kaunas, LT-48426
JSC Saules seimos medicinos centras
Kaunas, LT-49449
JSC Mano Seimos Gydytojas
Klaipėda, LT-94231
Private Doctor Family Clinic JSc Ausveja
Vilnius, LT-09108
Latvia4 sites
Association of Health Centres, Medical Centre "OLVI"
Daugavpils, LV-5410
D.Saulites-Kandevicas private practice
Liepāja, LV3401
SIS Klinika ALma
Riga, LV-1010
Health Center 4
Riga
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
- Conditions
- Osteoarthritis, Knee
- Being tested
- Diclofenac Sodium Gel 1%, Voltaren Gel, Placebo
- 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
Voltaren GelDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium Gel 1% | Experimental | Apply 4 g of gel to the knee four times a day Receives: Drug: Diclofenac Sodium Gel 1% |
| Voltaren Gel | Active comparator | Apply 4 g of gel to the knee four times a day Receives: Drug: Voltaren Gel |
| Placebo | Placebo comparator | Apply 4 g of gel to the knee four times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference.
WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20).
Measured: 8 weeks
Secondary outcomes (4)
An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score.
WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20).
Measured: 8 weeks
Incidences of Treatment Emergent Adverse Events
Measured: 8 weeks
Incidences of Abnormal Vital Signs
Measured: 8 weeks
Clinically Significant Changes From Baseline in Physical Examination Results
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionJun 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 934 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akorn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kalev Kask, Ph.D., Study director, EGeen International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913521
- Sponsor's protocol ID
- P130021
- Status last verified
- Jan 2021
- First submitted
- 22 Sep 2016
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02913521
- Acronym / sponsor ID
- P130021
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 934 participants (actual)
- Lead sponsor
- Akorn, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Sodium Gel 1% | Experimental | Drug: Diclofenac Sodium Gel 1%Apply 4 g of gel to the knee four times a day |
| Voltaren Gel | Active comparator | Drug: Voltaren GelApply 4 g of gel to the knee four times a day |
| Placebo | Placebo comparator | Drug: PlaceboApply 4 g of gel to the knee four times a day |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ambulatory male and non-pregnant females 35 years and older diagnosed with osteoarthritis according to the American College of Rheumatology Criteria (ACR) in one knee. Target knee is the one with higher level of pain.
- ACR Criteria includes: Knee Pain and at least 3 of the following: age ≥ 50, stiffness lasting < 30 mins, bony tenderness, crepitus, bony enlargement, and no palpable warmth.
- Symptom onset of > 6 Months prior to Screening for the target knee.
- If female and of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., IUD, oral, transdermal, injected, implanted hormonal contraceptives or condom + spermicide).
- Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).
Key exclusion criteria (22 listed)
- Females who are pregnant, breast feeding, or planning a pregnancy.
- Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale.
- History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
- After a minimum of 7-day wash out of all pain medication has Baseline pain on movement score of ≥ 20mm on a 0-100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
- Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) of the knee or 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% | Drug | Diclofenac Sodium Gel 1% |
| Voltaren Gel | Drug | Voltaren Gel |
| Placebo | Drug | Placebo |
Primary outcome
Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference.
Time frame: 8 weeks
WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20).
4 secondary outcomes
An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score.
Time frame: 8 weeks
Incidences of Treatment Emergent Adverse Events
Time frame: 8 weeks
Incidences of Abnormal Vital Signs
Time frame: 8 weeks
Clinically Significant Changes From Baseline in Physical Examination Results
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- 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.
Kalev Kask, Ph.D. study director
EGeen International Inc.
51 sites in 6 countries: 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, Knee, run by Akorn, Inc. at 51 sites in 6 countries.
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 10 inclusion and 22 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Estonia, Poland, Romania, Ukraine, Lithuania and 1 more country. 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 26 Feb 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 From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference. (time frame: 8 weeks). 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 26 Feb 2021.