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Completed

NCT Number: NCT04772781

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

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.

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Key information

Conditions

Low Back Pain, Mechanical Acute Low Back Pain Agnosia Back Pain Inflammation Low Back Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Apsen Farmacêutica S.A.

São Paulo, 04753-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S (+) - Ibuprofen

Drug

S (+) - Ibuprofen + placebo of Ibuflex®

Ibuflex®

Drug

Ibuflex® + placebo of S (+) - Ibuprofen

Primary outcomes

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

    Time frame: 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 outcomes

  1. Adverse events rates between groups

    Time frame: During treatment

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Registry information

Official study 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

Acronym: APS002/2020

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2021
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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