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

Low Back Pain Clinical Trial

— APS002/2020  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772781
• Other study ID #: APS002/2020
• Status: Completed
• Phase: Phase 2
• Start date: June 3, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: February 2023
• Source: Apsen Farmaceutica S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß - hCG urine test.

Related Conditions & MeSH terms

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

Intervention

Drug:
• S (+) - Ibuprofen
S (+) - Ibuprofen + placebo of Ibuflex®
• Ibuflex®
Ibuflex® + placebo of S (+) - Ibuprofen

Locations

Country	Name	City	State
Brazil	Apsen Farmacêutica S.A.	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Apsen Farmaceutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)	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)	Change from Baseline to 6 hours
Secondary	Adverse events rates between groups		During treatment