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

Study Overview
=================
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 diagnosed with osteoarthritis.

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 Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: S (+) - Ibuprofen
* Drug: Ibuvix® - ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S (+) - Ibuprofen<br>S (+) - Ibuprofen (1 coated tablet) + placebo of Ibuvix® - ibuprofen (1 coated tablet) Every 6 hours for 28 days. | Drug: S (+) - Ibuprofen<br>* S (+) - Ibuprofen + placebo of Ibuvix®<br>|
| Active Comparator: Ibuvix® - ibuprofen<br>Ibuvix® - ibuprofen (1 coated tablet) + placebo of S (+) - Ibuprofen (1 coated tablet) Every 6 hours for 28 days. | Drug: Ibuvix® - ibuprofen<br>* Ibuvix® + placebo of S(+) - Ibuprofen<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain) |  | Baseline (day 0) and Week 4 (day 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Improvement-I (PGI-I) |  | Week 4 (day 28) | 
| Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability |  | From Baseline (day 0) to Week 4 (day 28) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ibuprofen, Nonsteroidal anti-inflammatory, Pain, Inflammation, Anti-inflammatory, Pain control, Osteoarthritis, Pain relief, Enzyme Inhibitors