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

Akorn, Inc.50 sites in 6 countries934 target enrollmentJune 2015

ConditionsOsteoarthritis, Knee

InterventionsDiclofenac Sodium Gel 1%Voltaren Gel Placebo

DrugsDiclofenac Sodium Gel 1%Voltaren Gel Placebo

Overview

Phase: Phase 3
Intervention: Diclofenac Sodium Gel 1%
Conditions: Osteoarthritis, Knee
Sponsor: Akorn, Inc.
Enrollment: 934
Locations: 50
Primary Endpoint: Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

June 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akorn, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

Diclofenac Sodium Gel 1%

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

Intervention: Diclofenac Sodium Gel 1%

Voltaren Gel

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

Intervention: Voltaren Gel

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference.

Time Frame: 8 weeks

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).

Secondary Outcomes

Clinically Significant Changes From Baseline in Physical Examination Results(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.(8 weeks)
Incidences of Abnormal Vital Signs(8 weeks)
Incidences of Treatment Emergent Adverse Events(8 weeks)