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Proof-of Concept Study of Topical 3%-Diclofenac-Nano-Emulsion Cream for Knee OA Pain

This study has been completed.
Sponsor:
Information provided by:
Pharmos
ClinicalTrials.gov Identifier:
NCT00484120
First received: June 7, 2007
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: 3%-Diclofenac-Nano-Emulsion Cream
Drug: Placebo cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Proof-of Concept Study to Evaluate the Safety and Analgesic Efficacy of Topical 3%-Diclofenac-Nano-Emulsion Cream Versus Placebo for Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Pharmos:

Primary Outcome Measures:
  • Analgesic activity as measured by the WOMAC pain subscale. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's daily pain assessment in the home diary. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Pain on walking. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Safety and Tolerability. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 123
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
3% Diclofenac NE cream
Drug: 3%-Diclofenac-Nano-Emulsion Cream
3%-Diclofenac-Nano-Emulsion Cream
Placebo Comparator: 2 Drug: Placebo cream
Placebo cream

Detailed Description:

This will be a multi-center, double-blind, placebo-controlled, multiple-dose, parallel treatment study. A total of 126 subjects will be randomized to receive either 3%-Diclofenac-NE cream or a placebo cream respectively. Following screening and a washout period from previous treatments subjects will be enrolled and will self-apply the study medication. During the study, subjects will apply 3%-Diclofenac-NE or placebo cream three times daily for 28 days and complete a home-diary. Subjects will visit the clinic at mid-treatment for a follow up examination and again for a final examination at the end of treatment.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females 50 years of age and above.
  2. Patients with primary osteoarthritis in at least a single knee joint, grade 2 or 3 based on the Kellgren and Lawrence classification system.
  3. Radiographic evidence consistent with OA carried out within the 6 months before screening.
  4. Pain should have been present for at least half of the days in the previous month and for at least 48h prior to the screening visit.
  5. Eligible subjects must have used an oral, topical or rectal NSAID within the past 6 months before screening.
  6. At baseline, after a 1 week withdrawal period of analgesic/anti-inflammatory medications, subjects should have a flare of pain.
  7. Able to read, comprehend, and sign the consent form.
  8. Examined by the authorized physician and medically cleared to participate in the study.
  9. In general good health and have no contraindications to any of the investigational medicinal products.

Exclusion Criteria:

  1. Secondary osteoarthritis.
  2. Presence of a serious or unstable medical condition (e.g., malignancy, severe neurological impairment or uncontrolled hypertension) or poor general health interfering with compliance or assessment at the study physician's discretion.
  3. OA causing significant pain in any joint other than the knees.
  4. Any other rheumatic or non-rheumatic joint disease or any other painful condition within the past month (e.g. fibromyalgia).
  5. Knee surgery or other knee trauma at any time during the previous year or subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery etc.).
  6. Active or history of gastrointestinal ulceration or bleeding within the past 5 years.
  7. Presence of a significant active psychiatric disorder including major depression or subjects receiving anti-psychotic medication.
  8. Existence of any dermatological condition on the knee.
  9. Subjects with disabling congestive heart failure (CHF), angina, pulmonary disease.
  10. Clinically significant abnormal blood results.
  11. Subjects cannot have had an arthrocentesis prior or during the study.
  12. Concomitant treatment with physical and/or occupational therapy.
  13. Prior use of any type of NSAID or other analgesic before taking the first dose of investigational medicinal product. Rescue treatment will be allowed during the study
  14. Change in sedative or CNS/psychotropic agent within the past month.
  15. Chronic treatment with anticoagulants (e.g. Warfarin).
  16. Subjects under treatment with corticosteroids.
  17. Subjects using topical analgesics including OTC products.
  18. Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test.
  19. Active alcoholism or substance abuse.
  20. Has taken an investigational drug or has used an investigational device within the past 30 days.
  21. History of hypersensitivity and/or idiosyncrasy to diclofenac or excipients employed in this study, aspirin or other NSAIDS.
  22. Has previously been entered into this study.
  23. Any condition that in the investigator's judgement precludes participation in the study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484120

Locations
Israel
Barzilai Medical Center
Ashkelon, Israel, 78278
Rambam Medical Center
Haifa, Israel, 9602
Rabin Medical Center
Petah Tikva, Israel, 49100
Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Pharmos
Investigators
Principal Investigator: Eisenberg Elon, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Clinical Team, Pharmos Ltd
ClinicalTrials.gov Identifier: NCT00484120     History of Changes
Other Study ID Numbers: PH-2007-2
Study First Received: June 7, 2007
Last Updated: August 1, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Pharmos:
Osteoarthritis
Diclofenac
Nano-emulsion

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

ClinicalTrials.gov processed this record on November 25, 2014