Overview

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

Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Apsen Farmaceutica S.A.
Treatments:
Ibuprofen
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;