NCT04968158

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Acute Low Back Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-03-15
• Completion: 2022-04-10
• First posted: 2021-07-20
• Last updated: 2022-04-13

Locations

1 site across 1 country: Mexico