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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04772781

Acronym

APS002/2020

Enrollment

177

Registered

2021-02-26

Start date

2022-06-03

Completion date

2023-05-25

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pain control, Low back pain, Pain relief, Ibuprofen, Inflammation, Anti-inflammatory

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.

Interventions

DRUGS (+) - Ibuprofen

S (+) - Ibuprofen + placebo of Ibuflex®

DRUGIbuflex®

Ibuflex® + placebo of S (+) - Ibuprofen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Adverse events rates between groups	During treatment

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026