Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT02913521
• Date of registration: 22/09/2016
• Prospective Registration: No
• Primary sponsor: Akorn, Inc.
• Public title: Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%
• Scientific 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
• Date of first enrolment: June 2015
• Target sample size: 934
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02913521
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Estonia, Latvia, Lithuania, Poland, Romania, Ukraine

Contacts

• Name: Kalev Kask, Ph.D.
• Affiliation: EGeen International Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

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., IUD, oral,
transdermal, injected, implanted hormonal contraceptives or condom + spermicide).

4. Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that
required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).

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 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.

7. 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.

8. Willing and able to use only acetaminophen as rescue medication.

9. Willing and able to comply with the study requirements.

Exclusion Criteria:

1. Females who are pregnant, breast feeding, or planning a pregnancy.

2. Radiograph of the target knee within the previous year with a Grade 4 score on the
Kellgren-Lawrence disease severity scale.

3. History of osteoarthritis in the contralateral knee requiring medication (OTC or
prescription) within 12 months of screening.

4. 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.

5. Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty
arthritis) of the knee or rheumatoid arthritis.

6. 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.

7. 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.

8. History of coronary artery bypass graft within 6 months of screening.

9. 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.

10. Use of warfarin or other anticoagulant therapy within 30 days of screening.

11. Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30
days of screening or during the study.

12. Known history of gastrointestinal bleeding or peptic ulcer disease.

13. Abnormal screening clinical laboratory evaluations which the Investigator deems
clinically significant.

14. Known allergy to aspirin or NSAIDs.

15. Skin lesions or wounds in the affected area.

16. Significant (requiring surgery) injury or major knee surgery to either knee within six
months prior to screening.

17. Transaminase levels that are more than two times the upper limit of the normal range
at screening.

18. 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.

19. Concomitant use of corticosteroids (any formulation) or use within 30 days of study
randomization.

20. Receipt of any drug as part of a research study within 30 days prior to screening.

21. Previous randomization into this study.

22. Known allergy (hypersensitivity) to acetaminophen.



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis, Knee

Intervention(s)

Drug: Placebo

Drug: Voltaren Gel

Drug: Diclofenac Sodium Gel 1%

Primary Outcome(s)

Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference. [Time Frame: 8 weeks]

Secondary Outcome(s)

Incidences of Treatment Emergent Adverse Events [Time Frame: 8 weeks]

Incidences of Abnormal Vital Signs [Time Frame: 8 weeks]

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]

Clinically Significant Changes From Baseline in Physical Examination Results [Time Frame: 8 weeks]

Secondary ID(s)

P130021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/02/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02913521