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Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain

NCT04968158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-04-13

No results posted yet for this study

Summary

Phase IIIb, longitudinal, multicenter, randomized, open-label clinical trial to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain.

Conditions

  • Acute Low Back Pain

Interventions

DRUG

Etoricoxib 90 mg / Tramadol 50 mg

One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.

DRUG

Acetaminophen 325 mg / Tramadol 37.5 mg

One tablet, every 8 hours of 325 mg/ 37.5 m

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Miguel A Zurqui Ramírez, M.D · Icaro Investigación en Medicina S.A. de C.V.

  • Adelfia Urenda Quezada, M.D · Mediadvance Clinical S.A.P.I. de Quezada

  • Alejandro González Rebatu y González, M.D · Clinical Research Institute S.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-03-15
Completion
2022-04-10

Countries

  • Mexico

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 NCT04968158 on ClinicalTrials.gov