Clinical trial NCT01456611: Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteo Arthritis of the Knee
Lead sponsor: Anchen Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2011-10-21
Enrollment: 749
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in patients with osteoarthritis of the knee.

The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.


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) in one or both knees.

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., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives).

4. Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc) requiring the use of oral or topical treatments (NSAIDS or acetaminophen) for \> 15 days in the 30 days prior to Screening.

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 7 day wash out of all pain medication has baseline pain on movement score of ≥ 50mm on a 100-mm Visual Analogue Scale for the target knee.

7. After a 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. 24
3. History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
4. After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 20mm on a 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) or rheumatoid arthritis.
6. Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.
7. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
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 162mg 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 determines are clinically significant.
14. Known allergy to aspirin or NSAIDs.
15. Results from liver function tests that are more than two times the upper limit of the normal range at screening.
16. 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.
17. Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
18. Receipt of any drug as part of a research study within 30 days prior to screening.
19. Previous participation in this study.

Primary outcomes:
measure: Mean Change from Baseline in WOMAC Pain Scale
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Superiority of Test and Reference against Placebo in the Mean Change from baseline in the total WOMAC pain score.
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novum Investigator Site
state: Alabama
city: Huntsville
country: United States
facility: Novum Investigator Site
state: Alabama
city: Chandler
country: United States
facility: Novum Investigator Site
state: Arizona
city: Mesa
country: United States
facility: Novum Investigator Site
state: Arizona
city: Phoenix
country: United States
facility: Novum Investigator Site
state: Arizona
city: Tuscon
country: United States
facility: Novum Investigator Site
state: Arizona
city: Little Rock
country: United States
facility: Novum Investigator Site
state: Arkansas
city: Anaheim
country: United States
facility: Novum Investigator Site
state: California
city: Carmichael
country: United States
facility: Novum Investigator Site
state: California
city: Garden Grove
country: United States
facility: Novum Investigator Site
state: California
city: Long Beach
country: United States
facility: Novum Investigator Site
state: California
city: Sacramento
country: United States
facility: Novum Investigator Site
state: California
city: San Diego
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facility: Novum Investigator Site
state: California
city: Stock Bridge
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facility: Novum Investigator Site
state: California
city: Denver
country: United States
facility: Novum Investigator Site
state: Colorado
city: Norwalk
country: United States
facility: Novum Investigator Site
state: Connecticut
city: Stamford
country: United States
facility: Novum Investigator Site
state: Connecticut
city: Adventura
country: United States
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state: Florida
city: Bookville
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city: Bradenton
country: United States
facility: Novum Investigator Site
state: Florida
city: Daytona Beach
country: United States
facility: Novum Investigator Site
state: Florida
city: Hialeah
country: United States
facility: Novum Investigator Site
state: Florida
city: Jupiter
country: United States
facility: Novum Investigator Site
state: Florida
city: Miami
country: United States
facility: Novum Investigator Site
state: Florida
city: Ormond Beach
country: United States
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state: Florida
city: Pinellas Park
country: United States
facility: Novum Investigator Site
state: Florida
city: Sarasota
country: United States
facility: Novum Investigator Site
state: Florida
city: St. Petersburg
country: United States
facility: Novum Investigator Site
state: Florida
city: Tampa
country: United States
facility: Novum Investigator Site
state: Florida
city: Marietta
country: United States
facility: Novum Investigator Site
state: Georgia
city: Sandy Springs
country: United States
facility: Novum Investigator Site
state: Georgia
city: Lexington
country: United States
facility: Novum Investigator Site
state: Kentucky
city: New Orleans1
country: United States
facility: Novum Investigator Site
state: Louisiana
city: Hollywood
country: United States
facility: Novum Investigator Site
state: Maryland
city: Billings
country: United States
facility: Novum Investigator Site
state: Montana
city: Henderson
country: United States
facility: Novum Investigator Site
state: Nevada
city: Cary
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Charlotte
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Hickory
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facility: Novum Investigator Site
state: North Carolina
city: High Point
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Raleigh
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Salisbury
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Wilmington
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Cleveland
country: United States
facility: Novum Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Novum Investigator Site
state: Ohio
city: Beavercreek
country: United States
facility: Novum Investigator Site
state: Oklahoma
city: Norman
country: United States
facility: Novum Investigator Site
state: Oklahoma
city: Duncansville
country: United States
facility: Novum Investigator Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Novum Investigator Site
state: Tennessee
city: Houston
country: United States
facility: Novum Investigator Site
state: Texas
city: Longview
country: United States
facility: Novum Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Novum Investigator Site
state: Texas
city: Sugar Land
country: United States
facility: Novum Investigator Site
state: Texas
city: Charlottesville
country: United States
facility: Novum Investigator Site
state: Virginia
city: Midlothian
country: United States
facility: Novum Investigator Site
state: Virginia
city: Newport News
country: United States
facility: Novum Investigator Site
state: Virginia
Study officials:
References: