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.

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2014-002279-27-LV
• Date of registration: 04/09/2014
• Prospective Registration: Yes
• Primary sponsor: Hi-Tech Pharmacal Co., Inc.
• Public 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.
• 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: 11/11/2014
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002279-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Estonia, Latvia, Lithuania, Poland, Ukraine

Contacts

• Name: Managing Director
• Affiliation: AS EGeen

• Name: Managing Director
• Affiliation: AS EGeen

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) (Appendix 2) in target knee. Target knee is the one with higher level of pain.
ACR Criteria includes: Knee Pain and at least 3 of the following:
1) age = 50
2) stiffness lasting < 30 mins
3) bony tenderness
4) crepitus
5) bony enlargement
6) 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 (Appendix 3).
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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (Appendix 3).
3. History of osteoarthritis in the contralateral knee requiring medication 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 nor 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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

osteoarthritis of the knee

Intervention(s)

Product Name: Diclofenac Sodium Topical Gel 1%
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac Sodium
CAS Number: 15307-79-6
Other descriptive name: DICLOFENAC SODIUM
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous use

Trade Name: Voltaren® Gel
Product Name: Voltaren® Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac Sodium
CAS Number: 15307-79-6
Other descriptive name: DICLOFENAC SODIUM
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: at Week 8, Week 6 or Week 4

Main Objective: The objectives of the study are to demonstrate clinical bioequivalence of Hi-Tech Pharmacal Co., Inc’s Diclofenac Sodium Topical Gel 1% compared to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in the treatment of patients with osteoarthritis of the knee.

Secondary Objective: not applicable

Primary end point(s): • Mean Change from Baseline in WOMAC Pain Scale
Time Frame: Baseline and Week 8
• Equivalence of Test and Reference Drug in the Mean Change from baseline in the WOMAC pain score.
The analyses will be conducted in the Per-Protocol population using the WOMAC scores at Week 8.

Secondary Outcome(s)

Secondary end point(s): • Superiority of Test and Reference against Placebo in the Mean Change from baseline in the total WOMAC pain score.
Time Frame: Baseline and Week 8
The superiority of Test and Reference treatments over the placebo will be evaluated identically in Intent-to-Treat population using the WOMAC scores at Week 8, in separate ANCOVAs.

Timepoint(s) of evaluation of this end point: at Week 4, Week 6 or Week 8

Secondary ID(s)

DICL001

2014-002279-27-EE

Source(s) of Monetary Support

Hi-Tech Pharmacal Co., Inc.