Acute moderate to severe low back pain
Conditions
Brief summary
Mean change in VAS from baseline to 3 hours after administration
Detailed description
Mean change in VAS from baseline to 1 hour after administration, Proportion of patients with >30% reduction in pain intensity from baseline at 3 hours, Proportion of patients with >30% reduction in pain intensity from baseline at 1 hour, Mean change of Finger-to floor distance from baseline to 3 hours post administration, Mean change of Finger-to floor distance from baseline to 1 hour post administration, Proportion of patients withdrawn for reasons related to treatment and the proportion of patients experiencing adverse events
Interventions
DRUGDiclofenac+Thiocolchicoside/
Verisfield solution for injection
DRUGVoltaren 75 mg/3 ml ενέσιμο διάλυμα
Sponsors
Verisfield Single Member S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in VAS from baseline to 3 hours after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in VAS from baseline to 1 hour after administration, Proportion of patients with >30% reduction in pain intensity from baseline at 3 hours, Proportion of patients with >30% reduction in pain intensity from baseline at 1 hour, Mean change of Finger-to floor distance from baseline to 3 hours post administration, Mean change of Finger-to floor distance from baseline to 1 hour post administration, Proportion of patients withdrawn for reasons related to treatment and the proportion of patients experiencing adverse events | — |
Countries
Greece
Outcome results
None listed