NCT01471886

Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.

Detailed description

* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial. * Experiment duration: 04 days. * 03 visits (days 0, 2 and 4). * Efficacy will be evaluated for back pain relief based on visual analog scale. * Adverse events evaluation.

Conditions

• Back Pain

Interventions

Type	Name	Description
DRUG	Ketorolac Tromethamine	Every 8 hours for 4 days.
DRUG	Naproxen	Every 8 hours for 4 days.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-10-01
• Completion: 2013-11-11
• First posted: 2011-11-16
• Last updated: 2021-02-24

Locations

1 site across 1 country: Brazil