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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913521
• Other study ID #: P130021
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2021
• Source: Akorn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 934
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac Sodium Gel 1%

• Voltaren Gel

• Placebo

Locations

Country	Name	City	State
Estonia	Vee Family Doctor's Center OY	Paide
Estonia	OU Mai Perearstid	Parnu
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	Linna Health Cerntre	Tallinn
Estonia	Linnamoisa Perearstikeskus	Tallinn
Estonia	Medicum Ltd.	Tallinn
Estonia	OU Perearstikeskus Remedium	Tallinn
Estonia	Pirita Family Doctors Centre	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Dr.Monika Vask Ltd.	Tartu
Estonia	Ltd. Elli Kahar	Tartu
Estonia	Orthopaedic and Clinical Research Center	Tartu
Latvia	Association of Health Centres, Medical Centre "OLVI"	Daugavpils
Latvia	D.Saulites-Kandevicas private practice	Liepaja
Latvia	Health Center 4	Riga
Latvia	SIS Klinika ALma	Riga
Lithuania	InMedica	Kaunas
Lithuania	JSC Saules seimos medicinos centras	Kaunas
Lithuania	JSC Vita Longa	Kaunas
Lithuania	JSC Mano Seimos Gydytojas	Klaipeda
Lithuania	Private Doctor Family Clinic JSc Ausveja	Vilnius
Poland	CERMED	Bialystok
Poland	ClinicMed Badurski i Wspolnicy Spolka Jawna	Bialystok
Poland	St. Luke's hospital in Bielsko-Biala	Bielsko-Biala
Poland	Private medical practice Jacek Niski	Czestochowa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej ORTMED sp. z o.o.	Lodz
Poland	Clinical Best Solutions	Lublin
Poland	ZOZ w Olawie	Olawa
Poland	MEDICOME Sp. z o.o.	Oswiecim
Poland	Centrum Medyczne Luxmed, Przezmierowo	Poznan
Poland	"REUMA TIKA- Centrnrn Reurnatologii" NZOZ	Warsaw
Poland	Medical Chamber in Warsaw Nr 5718455	Warsaw	Mazovia
Romania	Spiratul Judetean de Urgenta Bacau	Bacau
Romania	Spital Judetean De Urgenta Bacau	Bacau
Romania	Dr Ion Stoia Rheumatology Center	Bucharest
Romania	Duo Medical	Bucharest
Romania	Emergency County Hospital SF Gheorghe	Bucharest
Romania	S.C. lanuli Med Consult Str Intr Lt. Dumitru Lemnea	Bucharest
Romania	RK Medcenter SRL	Iasi
Romania	S.C. Clinica Somesan	Marasti
Romania	Ploie?ti Municipal Hospital	Ploiesti
Ukraine	Communal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council"	Cherkasy
Ukraine	State Institution "Ukrainian State Scientific and Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine	Dnipropetrovsk
Ukraine	State Institution "Professor M.I. Sytenko Institute of Spine and Joint Patholo of the National Academ of Medical Sciences of Ukraine	Kharkiv
Ukraine	Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"	Kyiv
Ukraine	State Institution D.F.Chebotariov Institute of Gerontology of NAMS of Ukraine	Kyiv
Ukraine	State Institution D.F.Chebotariov Institute ofGerontolo!.!v ofNAMS of Ukraine - Dept of Age related changes to Muscoskeletal system	Kyiv
Ukraine	Communal Institution of.Lviv Regional Council "Yu. Lypa Lviv Regional Hospital of Disabled War Veterans and Former Political Prisoners"	Lviv
Ukraine	Odesa Regional Clinical Hospital	Odesa
Ukraine	MI Pyogrov Vinnystya Regional Clinical Hospital	Vinnytsya

Sponsors (1)

Lead Sponsor	Collaborator
Akorn, Inc.

Countries where clinical trial is conducted

Estonia,  Latvia,  Lithuania,  Poland,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 weeks
Secondary	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).	8 weeks
Secondary	Incidences of Treatment Emergent Adverse Events		8 weeks
Secondary	Incidences of Abnormal Vital Signs		8 weeks
Secondary	Clinically Significant Changes From Baseline in Physical Examination Results		8 weeks