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

Acute Low Back Pain Clinical Trial

Official title:
Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.

Clinical Trial 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.

Clinical Trial Description

Patients with back pain from the level of the lowest rib to the gluteal crease, with or without radiation to the legs, as a first-time episode or after another at least 6 months before and lasting no more than 6 weeks, that in the opinion of the doctor requires treatment with the combination of an anti-inflammatory and an analgesic. Study to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with the fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain. Evaluate and compare the average change in pain reported through the VAS at 3, 5 and 7 days with respect to its baseline measurement by treatment group. An exploratory analysis of the data will be carried out to identify aberrant, outliers, or missing values. To present the numerical variables, the measures of central tendency and dispersion appropriate to the distribution of the data will be used and the categorical variables will be expressed as frequency and percentage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04968158
Study type Interventional
Source Laboratorios Silanes S.A. de C.V.
Contact
Status Completed
Phase Phase 3
Start date November 29, 2021
Completion date April 10, 2022
View Details
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