Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Information source: Amneal Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Diclofenac Sodium Topical Gel, 1% (Drug); Voltaren Topical Gel, 1% (Drug); Vehicle Diclofenac Sodium Topical Gel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amneal Pharmaceuticals, LLC Official(s) and/or principal investigator(s): Prayag Shah, MD, Study Director, Affiliation: Amneal Pharmaceuticals, LLC
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: WOMAC Pain Score
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Goa Medical College, Goa 403716, India
Sunshine Hospitals, Secunderabad, Andhra Pradesh 500003, India
King George Hospital, Visakhapatnam, Andhra Pradesh 530002, India
King George Hospital, Visakhapatnam, Andra Pradesh 530002, India
B. J. Medical College & Hospital, Ahmedabad, Gujarat 380016, India
GMERS Medical College and Hospital, Ahmedabad, Gujarat 380061, India
Rathi Orthopedic and Research Centre, Ahmedabad, Gujarat 380 015, India
Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra, Junagadh, Gujarat 362 001, India
Centre For Knee Surgery, Vadodara, Gujarat 390007, India
Shree Giriraj Multispeciality Hospital, Rajkot, Gujurat 360007, India
St Johns Medical College, Bangalore, Karnataka 560034, India
K L E Societys Jawaharlal Nehry Medical College, Belgaum, Karnataka 590010, India
Mysore Medical College, Mysore, Karnataka 570001, India
Government Medical College, Calicut, Calicut, Kerala 673008, India
Psm Dept Ltmmc & Ltmg Hospital, Mumbai, Maharashtra 400022, India
Government Medical College, Nagpur, Maharashtra 440009, India
Jasleen Hospital, Nagpur, Maharashtra 440010, India
Lata Mangeshkar Hospital, Nagpur, Maharashtra 440019, India
Bj Medical College, Pune, Maharashtra 411001, India
Malpani Multispeciality Hospital, Jaipur, Rajasthan 302023, India
Apollo Speciality Hospitals, Madurai, Tamil Nadu 625020, India
King Georges Medical University, Lucknow, Uttar Pradesh 226003, India
M V Hospital and Research Centre, Lucknow, Uttar Pradesh 226 003, India
Additional Information
Starting date: April 2014
Last updated: June 23, 2015
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