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

Sponsor

Apsen Farmaceutica S.A. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04772781

Collaborator

(none)

168

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain, Mechanical Low Back Pain Acute Low Back Pain	Drug: S (+) - Ibuprofen Drug: Ibuflex®	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Adverse events rates between groups [During treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.