NCT06517823

Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain

Efficacy and Safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in the Treatment of Patients with Acute Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in Patients With Acute Low Back Pain

Detailed description

Researchers will compare the fixed-dose combination of Etoricoxib/Cyanocobalamin versus Etoricoxib in acute low back pain by comparing the proportion of patients that reported an improvement in pain during the 7 days of follow up. The adverse events related to the interventions will be registered during follow up. Participants will: * Be randomized into one of the 2 intervention groups (A or B) * Visit the clinic in 3 occasions (day 0, day 3 of follow up and day 7 of follow up) * In case needed the patient could take 50 mg of tramadol, as a rescue medication, previous authorization of de principal investigator

Conditions

• Acute Low-back Pain

Interventions

Type	Name	Description
DRUG	Etoricoxib + Cyanocobalamin fixed dose	One tablet of 90 mg / 0.50 mg a day
DRUG	Etoricoxib fixed dose	One pill of 90 mg a day

Timeline

• Start date: 2024-04-26
• Primary completion: 2024-10-04
• Completion: 2024-10-11
• First posted: 2024-07-24
• Last updated: 2024-11-27

Locations

1 site across 1 country: Mexico