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

NCT04772781 | Completed Phase 2

• 1 other identifier: APS002/2020
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Change from Baseline to 6 hours

Secondary Outcomes (1)

• Adverse events rates between groups

  During treatment

Study Arms (2)

S (+) - Ibuprofen

EXPERIMENTAL

Drug: S (+) - Ibuprofen

Ibuflex® - ibuprofen

ACTIVE COMPARATOR

Drug: Ibuflex®

Interventions

S (+) - Ibuprofen DRUG

S (+) - Ibuprofen + placebo of Ibuflex®

S (+) - Ibuprofen

Ibuflex® DRUG

Ibuflex® + placebo of S (+) - Ibuprofen

Ibuflex® - ibuprofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead

Study Sites (1)

Apsen Farmacêutica S.A.

São Paulo, 04753-001, Brazil

Location

MeSH Terms

Conditions

Low Back Pain; Agnosia; Inflammation

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: June 3, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)