NCT05222724

Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back Pain

Efficacy and Safety of the Combination of Ibuprofen and Paracetamol Versus Ibuprofen in Monotherapy in Acute Low Back Pain (LBP)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to assess the efficacy and safety of paracetamol/ibuprofen Fixed Dose Combination (FDC) compared to ibuprofen in patients with uncomplicated non-specific acute low back pain after a 3-day treatment period.

Detailed description

This is a Phase IV, multicenter, international, open-label, parallel-group study. The study will be conducted at sites located in Italy, Poland and Hungary. The sites will be outpatient facilities and hospitals. A total of 176 patients are planned to be included in the study This trial will be conducted in accordance with the study protocol, GCPs, Declaration of Helsinki (including up-to-date versions) and applicable regulatory requirements. The present clinical trial aims to evaluate the efficacy and safety of the combination of 2 tablets of paracetamol 500 mg/ibuprofen 150 mg administered 3 times daily, in the management of patients with acute non-specific Low Back Pain (LBP) condition.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Tachifene	paracetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).
DRUG	Brufen	ibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-10-05
• Completion: 2022-10-05
• First posted: 2022-02-03
• Last updated: 2023-01-31

Locations

11 sites across 2 countries: Italy, Poland