A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Phase III Therapeutic Superiority Trial Comparing the Efficacy and Tolerability of a Fixed-Dose Combination of Diclofenac + Orphenadrine + Paracetamol to Diclofenac (Cataflam®) and Orphenadrine + Paracetamol (Norgesic®) in Patients with Acute Severe Low Back Pain.

Condition studied

LOW BACK PAIN

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary endpoint is the cumulative, time-weighted sum of pain intensity differences (SPID), expressed as the sum of seven daily SPIDs from 0 to 6 hours post-dose (SPID0-6h) across the 7-day treatment period, compared between groups.

Endpoint detail

Average analgesic effect: The daily SPID0-6h for each one of the 7 treatment days, compared between groups., Rescue medication use: Mean number of rescue medication tablets consumed per participant from baseline to day 7 compared between groups., Responder rate: Proportion of patients achieving mild pain (e.g., VAS <45 mm) by day 7 compared between groups., Safety and tolerability: Incidence and proportion of participants experiencing adverse events throughout the study period compared between groups., Functional improvement: Mean percent change in Finger-to-Floor Distance (FFD) test score from baseline to day 7 compared between groups.