Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain (APS002/2020)

July 13, 2023 updated by: Apsen Farmaceutica S.A.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04753-001
        • Apsen Farmacêutica S.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S (+) - Ibuprofen
Drug: S (+) - Ibuprofen
S (+) - Ibuprofen + placebo of Ibuflex®
Active Comparator: Ibuflex® - ibuprofen
Drug: Ibuflex®
Ibuflex® + placebo of S (+) - Ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline to 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events rates between groups
Time Frame: During treatment
During treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apsen Farmaceutica S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2022

Primary Completion (Actual)

May 25, 2023

Study Completion (Actual)

May 25, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS002/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on S (+) - Ibuprofen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe