Status:
COMPLETED
Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
Lead Sponsor:
Abbott
Collaborating Sponsors:
Clintek
Conditions:
Osteoarthritis
Pain
Eligibility:
All Genders
18+ years
Brief Summary
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 osteoarthriti...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
519 Patients enrolled
Trial Details
Trial ID
NCT01226095
Start Date
June 1 2010
End Date
November 1 2010
Last Update
September 20 2013
Active Locations (15)
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1
Site Reference ID/Investigator# 42584
Alexandria, Egypt
2
Site Reference ID/Investigator# 42585
Alexandria, Egypt
3
Site Reference ID/Investigator# 42591
Alexandria, Egypt
4
Site Reference ID/Investigator# 42593
Alexandria, Egypt