Status:
COMPLETED
Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain
Lead Sponsor:
Apsen Farmaceutica S.A.
Conditions:
Low Back Pain, Mechanical
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2023
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT04772781
Start Date
June 3 2022
End Date
May 25 2023
Last Update
July 17 2023
Active Locations (1)
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1
Apsen Farmacêutica S.A.
São Paulo, Brazil, 04753-001