ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02913521
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Akorn, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Diclofenac Sodium Gel 1% Drug: Voltaren Gel Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Diclofenac Sodium Gel 1%
Apply 4 g of gel to the knee four times a day
Drug: Diclofenac Sodium Gel 1%
Active Comparator: Voltaren Gel
Apply 4 g of gel to the knee four times a day
Drug: Voltaren Gel
Placebo Comparator: Placebo
Apply 4 g of gel to the knee four times a day
Drug: Placebo



Primary Outcome Measures :
  1. Mean Change from Baseline to Week 8 in WOMAC Pain Scale [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Superiority of Test and Reference against Placebo in the Mean Change from Baseline to Week 8 in the total WOMAC Pain score. [ Time Frame: 8 weeks ]
  2. Incidences of treatment emergent adverse events [ Time Frame: 8 weeks ]
  3. Incidences of abnormal vital signs [ Time Frame: 8 weeks ]
  4. Clinically significant changes from Baseline in physical examination results [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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.

  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., IUD, oral, transdermal, injected, implanted hormonal contraceptives or condom + spermicide).
  4. Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).
  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 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.
  7. 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.
  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.
  3. History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
  4. 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.
  5. Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) of the knee or rheumatoid arthritis.
  6. 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.
  7. 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.
  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. 162 mg 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 deems clinically significant.
  14. Known allergy to aspirin or NSAIDs.
  15. Skin lesions or wounds in the affected area.
  16. Significant (requiring surgery) injury or major knee surgery to either knee within six months prior to screening.
  17. Transaminase levels that are more than two times the upper limit of the normal range at screening.
  18. 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.
  19. Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
  20. Receipt of any drug as part of a research study within 30 days prior to screening.
  21. Previous randomization into this study.
  22. Known allergy (hypersensitivity) to acetaminophen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913521


  Show 55 Study Locations
Sponsors and Collaborators
Akorn, Inc.
Investigators
Study Director: Kalev Kask, Ph.D. EGeen International Inc.

Responsible Party: Akorn, Inc.
ClinicalTrials.gov Identifier: NCT02913521     History of Changes
Other Study ID Numbers: P130021
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action