CompletedPhase 2

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

Brazil177 participantsStarted 2022-06-03

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)

Timeframe: Change from Baseline to 6 hours

Trial details

NCT IDNCT04772781

SponsorApsen Farmaceutica S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-25

View on ClinicalTrials.gov More Low Back Pain, Mechanical trials