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

Phase 2

Completed

• Conditions: Low Back Pain, Mechanical; Low Back Pain; Acute Low Back Pain
• Interventions: Drug: Ibuflex®; Drug: S (+) - Ibuprofen

• Registration Number: NCT04772781
• Lead Sponsor: Apsen Farmaceutica S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-02-26
• Study Start: 2022-06-03
• Status Verified: 2023-02
• Primary Completion: 2023-05-25
• Study Completion: 2023-05-25
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuflex® - ibuprofen	Ibuflex®	-
S (+) - Ibuprofen	S (+) - Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)	Change from Baseline to 6 hours	TOTPAR was calculated using data from a 5-point categorical pain relief scale (none = 0, slight = 1, moderate = 2, good = 3, or complete pain relief = 4)

Secondary Outcome Measures

Name	Time	Method
Adverse events rates between groups	During treatment

Trial Locations

Locations (1)

Apsen Farmacêutica S.A.; 🇧🇷 São Paulo, Brazil