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

NCT ID: NCT02913521

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 934 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-06-30

Brief 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

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Diclofenac Sodium Gel 1%

Apply 4 g of gel to the knee four times a day

Group Type: EXPERIMENTAL

Diclofenac Sodium Gel 1%

Intervention Type: DRUG

Voltaren Gel

Apply 4 g of gel to the knee four times a day

Group Type: ACTIVE_COMPARATOR

Voltaren Gel

Intervention Type: DRUG

Placebo

Apply 4 g of gel to the knee four times a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Diclofenac Sodium Gel 1%

Intervention Type: DRUG

Voltaren Gel

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akorn, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kalev Kask, Ph.D.

Role: STUDY_DIRECTOR

EGeen International Inc.

Locations

Vee Family Doctor's Center OY

Paide, , Estonia

OU Mai Perearstid

Pärnu, , Estonia

East Tallinn Central Hospital

Tallinn, , Estonia

West Tallinn Central Hospital

Tallinn, , Estonia

East Tallinn Central Hospital

Tallinn, , Estonia

Medicum Ltd.

Tallinn, , Estonia

Linna Health Cerntre

Tallinn, , Estonia

Linnamoisa Perearstikeskus

Tallinn, , Estonia

OU Perearstikeskus Remedium

Tallinn, , Estonia

Pirita Family Doctors Centre

Tallinn, , Estonia

Orthopaedic and Clinical Research Center

Tartu, , Estonia

Dr.Monika Vask Ltd.

Tartu, , Estonia

Ltd. Elli Kahar

Tartu, , Estonia

Association of Health Centres, Medical Centre "OLVI"

Daugavpils, , Latvia

D.Saulites-Kandevicas private practice

Liepāja, , Latvia

SIS Klinika ALma

Riga, , Latvia

Health Center 4

Riga, , Latvia

InMedica

Kaunas, , Lithuania

JSC Vita Longa

Kaunas, , Lithuania

JSC Saules seimos medicinos centras

Kaunas, , Lithuania

JSC Mano Seimos Gydytojas

Klaipėda, , Lithuania

Private Doctor Family Clinic JSc Ausveja

Vilnius, , Lithuania

Medical Chamber in Warsaw Nr 5718455

Warsaw, Masovian Voivodeship, 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

Częstochowa, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej ORTMED sp. z o.o.

Lodz, , Poland

Clinical Best Solutions

Lublin, , Poland

MEDICOME Sp. z o.o.

Oświęcim, , Poland

ZOZ w Olawie

Oława, , Poland

Centrum Medyczne Luxmed, Przezmierowo

Poznan, , Poland

"REUMA TIKA- Centrnrn Reurnatologii" NZOZ

Warsaw, , Poland

Spiratul Judetean de Urgenta Bacau

Bacau, , Romania

Spital Judetean De Urgenta Bacau

Bacau, , Romania

Duo Medical

Bucharest, , Romania

S.C. lanuli Med Consult Str Intr Lt. Dumitru Lemnea

Bucharest, , Romania

Dr Ion Stoia Rheumatology Center

Bucharest, , Romania

Emergency County Hospital SF Gheorghe

Bucharest, , Romania

RK Medcenter SRL

Iași, , Romania

S.C. Clinica Somesan

Mărăști, , Romania

Ploiești Municipal Hospital

Ploieşti, , Romania

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

Vinnytsia, , Ukraine

Countries

Estonia; Latvia; Lithuania; Poland; Romania; Ukraine

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P130021

Identifier Type: -

Identifier Source: org_study_id