An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis
| Autor: | Morris S. Gold, John H. Peniston, Lawrence K Alwine |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
musculoskeletal diseases
Adult Male medicine.medical_specialty WOMAC Diclofenac Administration Topical Physical Therapy Sports Therapy and Rehabilitation Physical examination Osteoarthritis law.invention Placebos Randomized controlled trial Double-Blind Method law medicine Humans Orthopedics and Sports Medicine Adverse effect Aged Pain Measurement Aged 80 and over medicine.diagnostic_test business.industry Anti-Inflammatory Agents Non-Steroidal Diclofenac Sodium Middle Aged Osteoarthritis Knee medicine.disease Treatment Outcome Tolerability Physical therapy Female business Gels medicine.drug |
| Zdroj: | The Physician and sportsmedicine. 39(3) |
| ISSN: | 0091-3847 |
| Popis: | To evaluate the long-term safety and tolerability of topical diclofenac sodium 1% gel (DSG) in the treatment of knee osteoarthritis (OA) for up to 12 months.This was a multicenter open-label, extension of two 3-month, randomized, double-blind studies of DSG in patients with knee OA (NCT ID: NCT00171691, "Safety of Diclofenac Sodium Gel in Knee Osteoarthritis"). To ensure adequate enrollment, some DSG-naïve patients with OA who had not participated in the double-blind studies were also enrolled. Patients applied 4 g DSG to 1 or both knees 4 times daily for 9 to 12 months. Safety was evaluated through adverse event (AE) reporting, physical examination, and laboratory investigations. Patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function scales every 3 months to assess long-term effectiveness.The extension study enrolled 583 patients; 294 patients completed the study. Use of DSG was documented for 578 patients (safety population). The mean age was 62.3 years, and 63.7% of patients were women. Overall, 112 (19.4%) patients reported ≥ 1 treatment-related AE, and the only treatment-related AE occurring in ≥ 1% of patients was application-site dermatitis. Treatment-related gastrointestinal, renal-function, hepatic-function, and cardiovascular AEs were reported by 3, 1, 2, and 0 patients, respectively. There were no serious AEs or deaths. At 1 year, improvements from baseline for WOMAC pain, stiffness, and physical function scale scores were 39.8%, 33.4%, and 36.9%, respectively.The long-term safety profile of DSG was consistent with previous 12-week studies, and DSG remained effective for a 1-year period. |
| Databáze: | OpenAIRE |
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