Efficacy and Safety of S (+) - Ibuprofen in Osteoarthritis Pain

Apsen Farmaceutica S.A.176 enrolled

Overview

The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals diagnosed with osteoarthritis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

176

Conditions

Osteoarthritis

Interventions

S (+) - IbuprofenDRUG

S (+) - Ibuprofen + placebo of Ibuvix®

Ibuvix® - ibuprofenDRUG

Ibuvix® + placebo of S(+) - Ibuprofen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Main Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Patients aged from 18 to 75 with a diagnosis of knee and/or hip osteoarthritis according to American College of Rheumatology (ACR) criteria. 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;

Locations (1)

Apsen Farmacêutica S.A.

São Paulo, Brazil

Outcomes

Primary Outcomes

Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)

Time frame: Baseline (day 0) and Week 4 (day 28)

Secondary Outcomes

Patient Global Impression of Improvement-I (PGI-I)

Time frame: Week 4 (day 28)

Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability

Time frame: From Baseline (day 0) to Week 4 (day 28)

Data from ClinicalTrials.gov

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