NCT04772781

Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain

National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With At Least Moderate Mechanical Acute Low Back Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Apsen Farmaceutica S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.

Conditions

• Low Back Pain, Mechanical
• Low Back Pain
• Acute Low Back Pain

Interventions

Type	Name	Description
DRUG	S (+) - Ibuprofen	S (+) - Ibuprofen + placebo of Ibuflex®
DRUG	Ibuflex®	Ibuflex® + placebo of S (+) - Ibuprofen

Timeline

• Start date: 2022-06-03
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2021-02-26
• Last updated: 2023-07-17

Locations

1 site across 1 country: Brazil