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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.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521578-32-00
Acronym
DI-OR-PA
Enrollment
224
Registered
2025-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LOW BACK PAIN

Brief summary

The primary endpoint is the mean percent change in Visual Analog Scale (VAS) pain score from baseline to Visit 4 across treatment groups

Detailed description

Analgesic efficacy (early response): Mean percent change in VAS score from baseline to Visit 3 between treatment groups., Rescue medication use: Mean number of rescue medication tablets consumed per participant from baseline to Visit 4 in each of the treatment arms., Responder rate: Proportion of patients achieving mild pain (e.g., VAS <45 mm) by Visit 4 in each group., Safety and tolerability: Incidence and proportion of participants experiencing adverse events throughout the study period in each of the treatment arms., Functional improvement (Visit 3 and Visit 4): Mean change in Finger-to-Floor Distance (FFD) test score from baseline to Visit 3 and Visit 4, respectively.

Interventions

DRUGNorgesic 35 mg / 450 mg δισκία
DRUGDEPON 500 mg δισκίο
DRUGPlacebo Red
DRUGDiclofenac + Orphenadrine + Paracetamol / Verisfield film-coated tablets
DRUGCATAFLAM Sugar Coated Tablets 50mg
DRUGPlacebo White

Sponsors

Verisfield Single Member S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the mean percent change in Visual Analog Scale (VAS) pain score from baseline to Visit 4 across treatment groups—

Secondary

MeasureTime frame
Analgesic efficacy (early response): Mean percent change in VAS score from baseline to Visit 3 between treatment groups., Rescue medication use: Mean number of rescue medication tablets consumed per participant from baseline to Visit 4 in each of the treatment arms., Responder rate: Proportion of patients achieving mild pain (e.g., VAS <45 mm) by Visit 4 in each group., Safety and tolerability: Incidence and proportion of participants experiencing adverse events throughout the study period in each of the treatment arms., Functional improvement (Visit 3 and Visit 4): Mean change in Finger-to-Floor Distance (FFD) test score from baseline to Visit 3 and Visit 4, respectively.—

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026