Osteo Arthritis of the KneePhase 3NCT01456611
Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%
A Phase 3 study testing Diclofenac in people with Osteo Arthritis of the Knee, run by Anchen Pharmaceuticals, Inc at 57 sites in United States.
Trial summary
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation 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
- Osteo Arthritis of the Knee
- What is being tested?
- Diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 749 participants
- Where
- 57 sitesUnited States
- Study dates
- Sep 2011to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 1. Ambulatory Male and Non Pregnant Females 35 years and older diagnosed with osteoarthritis (according to the American College of Rheumatology Criteria) in one or both knees.
- ACR Criteria includes, Knee Pain and at least 3 of the following:
- age ≥ 50
- stiffness lasting < 30 mins
- bony tenderness
- crepitus
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- bony enlargement
- no palpable warmth
- 2. Symptom onset of > 6 Months prior to Screening for the target knee.
- 3. 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., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
- 4. Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc) requiring the use of oral or topical treatments (NSAIDS or acetaminophen) for > 15 days in the 30 days prior to Screening.
- 5. 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.
- 6. After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 50mm on a 100-mm Visual Analogue Scale for the target knee.
- 7. After a 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.
- 8. Willing and able to use only acetaminophen as rescue medication
- 9. 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. 24
- History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
- After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 20mm on a 100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
- Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) or rheumatoid arthritis.
- Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.
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- History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
- 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 162mg 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 determines are clinically significant.
- Known allergy to aspirin or NSAIDs.
- Results from liver function tests 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 participation in this study.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Novum Investigator Site
Adventura, Florida
Novum Investigator Site
Anaheim, California
Novum Investigator Site
Beavercreek, Oklahoma
Novum Investigator Site
Billings, Montana
Novum Investigator Site
Birmingham, Alabama
Novum Investigator Site
Bookville, Florida
Novum Investigator Site
Bradenton, Florida
Novum Investigator Site
Carmichael, California
Novum Investigator Site
Cary, North Carolina
Novum Investigator Site
Chandler, Arizona
Novum Investigator Site
Charlotte, North Carolina
Novum Investigator Site
Charlottesville, Virginia
Novum Investigator Site
Chattanooga, Tennessee
Novum Investigator Site
Cleveland, Ohio
Novum Investigator Site
Columbus, Ohio
Novum Investigator Site
Daytona Beach, Florida
Novum Investigator Site
Denver, Colorado
Novum Investigator Site
Duncansville, Pennsylvania
Novum Investigator Site
Garden Grove, California
Novum Investigator Site
Henderson, Nevada
Novum Investigator Site
Hialeah, Florida
Novum Investigator Site
Hickory, North Carolina
Novum Investigator Site
High Point, North Carolina
Novum Investigator Site
Hollywood, Maryland
Novum Investigator Site
Houston, Texas
Novum Investigator Site
Huntsville, Alabama
Novum Investigator Site
Jupiter, Florida
Novum Investigator Site
Lexington, Kentucky
Novum Investigator Site
Little Rock, Arkansas
Novum Investigator Site
Long Beach, California
Novum Investigator Site
Longview, Texas
Novum Investigator Site
Marietta, Georgia
Novum Investigator Site
Mesa, Arizona
Novum Investigator Site
Miami, Florida
Novum Investigator Site
Midlothian, Virginia
Novum Investigator Site
New Orleans1, Louisiana
Novum Investigator Site
Newport News, Virginia
Novum Investigator Site
Norman, Oklahoma
Novum Investigator Site
Norwalk, Connecticut
Novum Investigator Site
Ormond Beach, Florida
Novum Investigator Site
Phoenix, Arizona
Novum Investigator Site
Pinellas Park, Florida
Novum Investigator Site
Raleigh, North Carolina
Novum Investigator Site
Sacramento, California
Novum Investigator Site
Salisbury, North Carolina
Novum Investigator Site
San Antonio, Texas
Novum Investigator Site
San Diego, California
Novum Investigator Site
Sandy Springs, Georgia
Novum Investigator Site
Sarasota, Florida
Novum Investigator Site
St. Petersburg, Florida
Novum Investigator Site
Stamford, Connecticut
Novum Investigator Site
Stock Bridge, California
Novum Investigator Site
Sugar Land, Texas
Novum Investigator Site
Tampa, Florida
Novum Investigator Site
Tuscon, Arizona
Novum Investigator Site
Wilmington, North Carolina
Novum Investigator Site
Winston-Salem, North Carolina
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in patients with osteoarthritis of the knee.
The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- Diclofenac, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Diclofenac Sodium Gel 1%
PlaceboDrug
Placebo Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium Gel | Experimental | Diclofenac sodium Topical Gel 1% Receives: Drug: Diclofenac |
| Voltaren (R) Gel | Active comparator | Voltaren (R) Gel 1% Receives: Drug: Diclofenac |
| Placebo | Placebo comparator | Placebo Topical Gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in WOMAC Pain Scale
Measured: Baseline and Week 4
Secondary outcomes (1)
Superiority of Test and Reference against Placebo in the Mean Change from baseline in the total WOMAC pain score.
The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline in the total WOMAC pain score is statistically significantly greater (p<0.05) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.
The analyses will be conducted in the mITT population.
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 posted21 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anchen Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456611
- Sponsor's protocol ID
- DCL-269
- Status last verified
- Jul 2012
- First submitted
- 18 Oct 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01456611
- Acronym / sponsor ID
- DCL-269
- Conditions
- Osteo Arthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- Anchen Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in patients with osteoarthritis of the knee.
The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.
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 Gel | Experimental | Drug: DiclofenacDiclofenac sodium Topical Gel 1% |
| Voltaren (R) Gel | Active comparator | Drug: DiclofenacVoltaren (R) Gel 1% |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Topical Gel |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Ambulatory Male and Non Pregnant Females 35 years and older diagnosed with osteoarthritis (according to the American College of Rheumatology Criteria) in one or both knees.
- age ≥ 50
- stiffness lasting < 30 mins
- bony tenderness
- crepitus
Key exclusion criteria (19 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. 24
- History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
- After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 20mm on a 100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
- Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) 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 |
|---|---|---|
| DiclofenacDiclofenac Sodium Gel 1% | Drug | Diclofenac Sodium Gel, Voltaren (R) Gel |
| PlaceboPlacebo Topical Gel | Drug | Placebo |
Primary outcome
Mean Change from Baseline in WOMAC Pain Scale
Time frame: Baseline and Week 4
1 secondary outcome
Superiority of Test and Reference against Placebo in the Mean Change from baseline in the total WOMAC pain score.
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
57 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 in people with Osteo Arthritis of the Knee, run by Anchen Pharmaceuticals, Inc at 57 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 16 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 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in WOMAC Pain Scale (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 12 Jul 2012.