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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
S (+) - Ibuprofen
Ibuflex®
Sponsored by
Apsen Farmaceutica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Pain control, Low back pain, Pain relief, Ibuprofen, Inflammation, Anti-inflammatory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Apsen Farmacêutica S.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S (+) - Ibuprofen

Ibuflex® - ibuprofen

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Adverse events rates between groups

Full Information

First Posted
February 23, 2021
Last Updated
July 13, 2023
Sponsor
Apsen Farmaceutica S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04772781
Brief Title
Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain
Acronym
APS002/2020
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apsen Farmaceutica S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical, Low Back Pain, Acute Low Back Pain
Keywords
Pain control, Low back pain, Pain relief, Ibuprofen, Inflammation, Anti-inflammatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S (+) - Ibuprofen
Arm Type
Experimental
Arm Title
Ibuflex® - ibuprofen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
S (+) - Ibuprofen
Intervention Description
S (+) - Ibuprofen + placebo of Ibuflex®
Intervention Type
Drug
Intervention Name(s)
Ibuflex®
Intervention Description
Ibuflex® + placebo of S (+) - Ibuprofen
Primary Outcome Measure Information:
Title
At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)
Description
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 Outcome Measure Information:
Title
Adverse events rates between groups
Time Frame
During treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Apsen Farmacêutica S.A.
City
São Paulo
ZIP/Postal Code
04753-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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