Osteoarthritis
Conditions
Keywords
Nonsteroidal anti-inflammatory, Pain, Ibuprofen, Inflammation, Anti-inflammatory, Pain control, Osteoarthritis, Pain relief, Enzyme Inhibitors
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.
Interventions
S (+) - Ibuprofen + placebo of Ibuvix®
DRUGIbuvix® - ibuprofen
Ibuvix® + placebo of S(+) - Ibuprofen
Sponsors
Apsen Farmaceutica S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain) | Baseline (day 0) and Week 4 (day 28) |
Secondary
| Measure | 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) |
Countries
Brazil
Outcome results
None listed