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

Apsen Farmaceutica

Status and phase: Completed; Phase 2

Conditions: Low Back Pain, Mechanical; Acute Low Back Pain; Low Back Pain

Treatments: Drug: Ibuflex®; Drug: S (+) - Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT04772781

APS002/2020

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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177 participants in 2 patient groups

S (+) - Ibuprofen

Experimental group

Treatment:

Drug: S (+) - Ibuprofen

Ibuflex® - ibuprofen

Active Comparator group

Treatment:

Drug: Ibuflex®