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An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis.
Phys Sportsmed. 2011 Sep; 39(3):31-8.PS

Abstract

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

The long-term safety profile of DSG was consistent with previous 12-week studies, and DSG remained effective for a 1-year period.

Authors+Show Affiliations

Feasterville Family Health Care Center, Feasterville, PA, USA. jhpdo@aol.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22030938

Citation

Peniston, John H., et al. "An Open-label, Long-term Safety and Tolerability Trial of Diclofenac Sodium 1% Gel in Patients With Knee Osteoarthritis." The Physician and Sportsmedicine, vol. 39, no. 3, 2011, pp. 31-8.
Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011;39(3):31-8.
Peniston, J. H., Gold, M. S., & Alwine, L. K. (2011). An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. The Physician and Sportsmedicine, 39(3), 31-8. https://doi.org/10.3810/psm.2011.09.1918
Peniston JH, Gold MS, Alwine LK. An Open-label, Long-term Safety and Tolerability Trial of Diclofenac Sodium 1% Gel in Patients With Knee Osteoarthritis. Phys Sportsmed. 2011;39(3):31-8. PubMed PMID: 22030938.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. AU - Peniston,John H, AU - Gold,Morris S, AU - Alwine,Lawrence K, PY - 2011/10/28/entrez PY - 2011/10/28/pubmed PY - 2012/1/27/medline SP - 31 EP - 8 JF - The Physician and sportsmedicine JO - Phys Sportsmed VL - 39 IS - 3 N2 - OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: The long-term safety profile of DSG was consistent with previous 12-week studies, and DSG remained effective for a 1-year period. SN - 0091-3847 UR - https://www.unboundmedicine.com/medline/citation/22030938/An_open_label_long_term_safety_and_tolerability_trial_of_diclofenac_sodium_1_gel_in_patients_with_knee_osteoarthritis_ L2 - https://ClinicalTrials.gov/search/term=22030938 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -