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

Low Back Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05222724
Study type Interventional
Source Aziende Chimiche Riunite Angelini Francesco S.p.A
Contact
Status Completed
Phase Phase 4
Start date December 1, 2021
Completion date October 5, 2022
View Details
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