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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-03

Study Completion Date

2023-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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S (+) - Ibuprofen

Group Type EXPERIMENTAL

S (+) - Ibuprofen

Intervention Type DRUG

S (+) - Ibuprofen + placebo of Ibuflex®

Ibuflex® - ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuflex®

Intervention Type DRUG

Ibuflex® + placebo of S (+) - Ibuprofen

Interventions

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S (+) - Ibuprofen

S (+) - Ibuprofen + placebo of Ibuflex®

Intervention Type DRUG

Ibuflex®

Ibuflex® + placebo of S (+) - Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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;

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No