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

NCT02913521 | Completed Phase 3 Results

• 1 other identifier: P130021
• Study Type: interventional
• Target: 934
• Locations: 6 countries
• Sites: 51

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  8 weeks

• Incidences of Treatment Emergent Adverse Events

  8 weeks

• Incidences of Abnormal Vital Signs

  8 weeks

• Clinically Significant Changes From Baseline in Physical Examination Results

  8 weeks

Study Arms (3)

Diclofenac Sodium Gel 1%

EXPERIMENTAL

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

Drug: Diclofenac Sodium Gel 1%

Voltaren Gel

ACTIVE COMPARATOR

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

Drug: Voltaren Gel

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Diclofenac Sodium Gel 1% DRUG

Diclofenac Sodium Gel 1%

Voltaren Gel DRUG

Voltaren Gel

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Symptom onset of \> 6 Months prior to Screening for the target knee.
• 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).
• Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).
• 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.
• 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.
• 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.
• Willing and able to use only acetaminophen as rescue medication.
• Willing and able to comply with the study requirements.

You may not qualify if:

• 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.
• History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
• 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.
• Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) of the knee or rheumatoid arthritis.
• 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.
• 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.
• 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. 162 mg 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 deems clinically significant.
• Known allergy to aspirin or NSAIDs.
• Skin lesions or wounds in the affected area.

Sponsors & Collaborators

• Akorn, Inc.: lead

Study Sites (51)

Vee Family Doctor's Center OY

Paide, 72713, Estonia

Location

OU Mai Perearstid

Pärnu, 85010, Estonia

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

East Tallinn Central Hospital

Tallinn, 11312, Estonia

Location

Medicum Ltd.

Tallinn, 13619, Estonia

Location

Linna Health Cerntre

Tallinn, Estonia

Location

Linnamoisa Perearstikeskus

Tallinn, Estonia

Location

OU Perearstikeskus Remedium

Tallinn, Estonia

Location

Pirita Family Doctors Centre

Tallinn, Estonia

Location

Orthopaedic and Clinical Research Center

Tartu, 50410, Estonia

Location

Dr.Monika Vask Ltd.

Tartu, 51014, Estonia

Location

Ltd. Elli Kahar

Tartu, Estonia

Location

Association of Health Centres, Medical Centre "OLVI"

Daugavpils, LV-5410, Latvia

Location

D.Saulites-Kandevicas private practice

Liepāja, LV3401, Latvia

Location

SIS Klinika ALma

Riga, LV-1010, Latvia

Location

Health Center 4

Riga, Latvia

Location

InMedica

Kaunas, LT-48259, Lithuania

Location

JSC Vita Longa

Kaunas, LT-48426, Lithuania

Location

JSC Saules seimos medicinos centras

Kaunas, LT-49449, Lithuania

Location

JSC Mano Seimos Gydytojas

Klaipėda, LT-94231, Lithuania

Location

Private Doctor Family Clinic JSc Ausveja

Vilnius, LT-09108, Lithuania

Location

Medical Chamber in Warsaw Nr 5718455

Warsaw, Masovian Voivodeship, 00-341, Poland

Location

CERMED

Bialystok, 15-270, Poland

Location

ClinicMed Badurski i Wspolnicy Spolka Jawna

Bialystok, 15-879, Poland

Location

St. Luke's hospital in Bielsko-Biala

Bielsko-Biala, 43-300, Poland

Location

Private medical practice Jacek Niski

Częstochowa, I04/118, Poland

Location

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

Lodz, 91-498, Poland

Location

Clinical Best Solutions

Lublin, 20-059, Poland

Location

MEDICOME Sp. z o.o.

Oświęcim, 32-600, Poland

Location

ZOZ w Olawie

Oława, 55-200, Poland

Location

Centrum Medyczne Luxmed, Przezmierowo

Poznan, 60-773, Poland

Location

"REUMA TIKA- Centrnrn Reurnatologii" NZOZ

Warsaw, 02-69 l, Poland

Location

Spiratul Judetean de Urgenta Bacau

Bacau, 600114, Romania

Location

Spital Judetean De Urgenta Bacau

Bacau, Romania

Location

Duo Medical

Bucharest, 010584, Romania

Location

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

Bucharest, 010976, Romania

Location

Dr Ion Stoia Rheumatology Center

Bucharest, 020983, Romania

Location

Emergency County Hospital SF Gheorghe

Bucharest, 520064, Romania

Location

RK Medcenter SRL

Iași, 700127, Romania

Location

S.C. Clinica Somesan

Mărăști, Romania

Location

Ploiești Municipal Hospital

Ploieşti, 100337, Romania

Location

Communal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council"

Cherkasy, 18009, Ukraine

Location

State Institution "Ukrainian State Scientific and Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine

Dnipropetrovsk, 49027, Ukraine

Location

State Institution "Professor M.I. Sytenko Institute of Spine and Joint Patholo of the National Academ of Medical Sciences of Ukraine

Kharkiv, 61024, Ukraine

Location

Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"

Kyiv, 04107, Ukraine

Location

State Institution D.F.Chebotariov Institute of Gerontology of NAMS of Ukraine

Kyiv, 04114, Ukraine

Location

State Institution D.F.Chebotariov Institute ofGerontolo!.!v ofNAMS of Ukraine - Dept of Age related changes to Muscoskeletal system

Kyiv, 04114, Ukraine

Location

Communal Institution of.Lviv Regional Council "Yu. Lypa Lviv Regional Hospital of Disabled War Veterans and Former Political Prisoners"

Lviv, 79495, Ukraine

Location

Odesa Regional Clinical Hospital

Odesa, 65025, Ukraine

Location

MI Pyogrov Vinnystya Regional Clinical Hospital

Vinnytsia, 21018, Ukraine

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Kalev Kask
• Organization: Egeen

kalev.kask@egeeninc.com

16504690600

Study Officials

• Kalev Kask, Ph.D.

  EGeen International Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 23, 2016
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (11); RO (9); UA (9); ES (13); LA (4); LI (5)