Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients

Abbott

Status: Completed

Conditions: Morning Stiffness; Osteoarthritis; Pain

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01226095

P12-162

Details and patient eligibility

About

This is a prospective, multi-center, post-marketing observational study to evaluate the effectiveness and compliance of ibuprofen in a sustained release form in the treatment of Egyptian osteoarthritic patients.

Full description

This was a prospective, longitudinal, multicenter observational study conducted in a clinical practice setting where the study product was used in osteoarthritis patients as indicated in the approved package insert; the dosing regimen of Brufen retard is 2 tablets as a single dose once daily.

Enrollment: 519 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients seeking treatment for osteoarthritis and there are clinical or radiological evidence of the disease,
• Male or female, age ≥ 18
• Designated to treatment with Ibuprofen in a sustained release form (Brufen Retard) according to the best criterion of the physician and if he decides to treat the patient according to labeled indication and dose for 4 weeks.
• Patients who have given their written informed consent to participate in the study
• Patients who are currently taking non steroidal anti inflammatory drugs (NSAIDs), should complete an initial washout phase 10 days depending on the half life of the drug taken

Exclusion criteria

• Contraindications as described in company core data sheet (CCDS) and specifically
• Patients with active peptic ulcer
• Patients who have presented reactions of hypersensitivity (asthma , rhinitis or urticaria ) with ibuprofen or other anti-inflammatory non steroids
• Patients with active cardiovascular disease and those taking aspirin/warfarin for prophylaxis for myocardial infarction (MI) or stroke
• Patients with moderate to severe renal diseases
• Patients with moderate to severe hepatic disease
• Patients with Crohn's disease
• Patients included currently in another study
• Women of childbearing potential must not be pregnant
• Any patients the investigators consider ineligible for this study

Trial design

519 participants in 1 patient group

Osteoarthritic patients

Description:

Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis