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

NCT05222724 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2023-01-31

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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).

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-10-05
Completion
2022-10-05

Countries

  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222724 on ClinicalTrials.gov