Clinical trial NCT02121002: Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Official title: A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Knee
Lead sponsor: Amneal Pharmaceuticals, LLC
Sponsor class: INDUSTRY
Collaborators: name: Sristek Clinical Research Solutions Limited
First posted: 2014-04-23
Enrollment: 1176
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: To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
* Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
* After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
* If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
* Able to tolerate rescue medication with paracetamol/acetaminophen.

Exclusion Criteria:

* Pregnant or lactating or planning to become pregnant during the study period.
* X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
* History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
* After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
* History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
* History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
* History of gastrointestinal bleeding or peptic ulcer disease.
* Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
* Elevated transaminases at screening.
* Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.
* Concomitant use of corticosteroids or use within 30 days of study randomization.
* Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
* Known allergy to aspirin or nonsteroidal anti-inflammatory drug
* Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
* Receipt of any drug as part of a research study within 30 days prior to screening.
* Previous participation in this study.
* Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
* Recent history of major knee injury or surgery.
* Known history of positive HIV

Primary outcomes:
measure: Change From Baseline to 4 Weeks in WOMAC Pain Score
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Secunderabad
country: India
facility: Sunshine Hospitals
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andra Pradesh
city: Ahmedabad
country: India
facility: Rathi Orthopedic and Research Centre
state: Gujarat
city: Ahmedabad
country: India
facility: B. J. Medical College & Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: GMERS Medical College and Hospital
state: Gujarat
city: Junagadh
country: India
facility: Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra
state: Gujarat
city: Vadodara
country: India
facility: Centre For Knee Surgery
state: Gujarat
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
state: Gujurat
city: Bangalore
country: India
facility: St Johns Medical College
state: Karnataka
city: Belgaum
country: India
facility: K L E Societys Jawaharlal Nehry Medical College
state: Karnataka
city: Mysore
country: India
facility: Mysore Medical College
state: Karnataka
city: Calicut
country: India
facility: Government Medical College, Calicut
state: Kerala
city: Mumbai
country: India
facility: Psm Dept Ltmmc & Ltmg Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College
state: Maharashtra
city: Nagpur
country: India
facility: Jasleen Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Lata Mangeshkar Hospital
state: Maharashtra
city: Pune
country: India
facility: Bj Medical College
state: Maharashtra
city: Jaipur
country: India
facility: Malpani Multispeciality Hospital
state: Rajasthan
city: Madurai
country: India
facility: Apollo Speciality Hospitals
state: Tamil Nadu
city: Lucknow
country: India
facility: M V Hospital and Research Centre
state: Uttar Pradesh
city: Lucknow
country: India
facility: King Georges Medical University
state: Uttar Pradesh
city: Goa
country: India
facility: Goa Medical College
Study officials:
affiliation: Amneal Pharmaceuticals, LLC
name: Prayag Shah, MD
role: STUDY_DIRECTOR
References: