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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

519 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis Pain Morning Stiffness

Keywords

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Osteoarthritis Pain Morning stiffness

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Osteoarthritic patients

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rasha Eldessouky, MBBC

Role: STUDY_DIRECTOR

Abbott (Egypt)

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Egypt

Other Identifiers

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P12-162

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Osteoarthritic patients

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Clintek

Abbott

Responsible Party

Principal Investigators

Rasha Eldessouky, MBBC

Locations

Site Reference ID/Investigator# 42584

Site Reference ID/Investigator# 42585

Site Reference ID/Investigator# 42591

Site Reference ID/Investigator# 42593

Site Reference ID/Investigator# 42594

Site Reference ID/Investigator# 29755

Site Reference ID/Investigator# 42582

Site Reference ID/Investigator# 42583

Site Reference ID/Investigator# 42586

Site Reference ID/Investigator# 42587

Site Reference ID/Investigator# 42588

Site Reference ID/Investigator# 42589

Site Reference ID/Investigator# 42590

Site Reference ID/Investigator# 42592

Site Reference ID/Investigator# 42595

Countries

Other Identifiers

P12-162