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

Apsen Farmaceutica S.A.177 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

177

Conditions

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

Interventions

S (+) - IbuprofenDRUG

S (+) - Ibuprofen + placebo of Ibuflex®

Ibuflex®DRUG

Ibuflex® + placebo of S (+) - Ibuprofen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Apsen Farmacêutica S.A.

São Paulo, Brazil

Outcomes

Primary Outcomes

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)

Time frame: Change from Baseline to 6 hours

Secondary Outcomes

Adverse events rates between groups

Time frame: During treatment

Data from ClinicalTrials.gov

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