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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apsen Farmaceutica S.A.
• Treatments: Ibuprofen

Criteria

Main Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;

• Patient with acute low back pain who responds to the pain period less than or equal to 3 days;

Main Exclusion Criteria:

• Known hypersensitivity to the formula components used during the clinical trial;

• Previous history of alcohol or drugs abuse diagnosed by DSM-V;

• Current or previous history (less than 12 months) of smoking;

• Have clinically relevant abnormal laboratory results according to medical evaluation;

• Women who are pregnant, lactating, or positive for β - hCG urine test.