Study to demonstrate the pain reduction efficacy and tolerability of SST-4005, a topical Naproxen cream in the treatment of chronic low back pain

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2009
INTERVENTION: Intervention1: SST‐4005, a Topical Naproxen Cream: 500mg/10 ml twice daily for 14 days Control Intervention1: Matching Topical Placebo Cream: 500mg/10 ml twice daily for 14 days CONDITION: Chronic Low back pain PRIMARY OUTCOME: Changes from baseline to end of trial in 'low back pain intensity' on 0‐100 mm Visual Analog Scale(VAS)‐‐‐‐‐‐Timepoint: After 2 weeks SECONDARY OUTCOME: 1. Mean 0‐100 mm VAS Scores during the treatment period.; 2. Changes from baseline to end of trial in Roland Morris Disability Questionnaire (RMDQ‐24); 3. Mean number of nighttime awakenings due to pain and quality of sleep.; 4. Patient reported global assessment of treatment.; 5. Physician's Global Assessment of subjects LBP.; 6. Use of rescue medication.; ‐‐‐‐‐‐Timepoint: After 2 weeks Safety outcomes:; 1. Treatment emergent adverse events(TEAEs); 2. Incidence of application site reactions.‐‐‐‐‐‐Timepoint: After 2 weeks. INCLUSION CRITERIA: 1. Age 18‐60 years of either gender 2. Low back pain (inferior to T‐12 and superior to gluteal fold) lasting more than 12 weeks due to spondylosis, degenerative spinal disease or pain of nonspecific origin. 3. Post washout period baseline pain intensity score>40 on a 0‐100mm numerical ratring scale(VAS) 4. Willingness to provide informed consent to participate in the study.
Epistemonikos ID: d49330af1457b4d74db24b1b4af3d6663df2ace4
First added on: Aug 22, 2024