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

Completed

Conditions: Osteoarthritis
Pain
Morning Stiffness

Registration Number: NCT01226095

Lead Sponsor: Abbott

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 osteoarthritic patients.

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 package insert; the dosing regimen of Brufen retard is 2 tablets as a single dose once daily.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 519

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.	Baseline and 4 weeks	Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.
Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).	4 weeks	Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.

Secondary Outcome Measures

Name	Time	Method
Percent of Participant Compliance	2 and 4 weeks	The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).
Number of Participants With Joint Tenderness/Stiffness at Each Visit	Baseline, 2 weeks, and 4 weeks	Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).	2 and 4 weeks	Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.
Duration of Morning Stiffness	Baseline, 2 weeks, and 4 weeks	The duration of morning stiffness in minutes was assessed at each visit.
Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)	2 and 4 weeks	The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit	Baseline, 2 weeks, and 4 weeks	The number of participants who were able or unable to carry out normal activities was assessed at each visit.
Number of Participants Who Experienced Adverse Events and Serious Adverse Events	Baseline to 4 weeks	Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.

Trial Locations

Locations (15): Site Reference ID/Investigator# 42584
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Alexandria, Egypt
Site Reference ID/Investigator# 42585
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Alexandria, Egypt
Site Reference ID/Investigator# 42591
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Alexandria, Egypt
Site Reference ID/Investigator# 42594
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Alexandria, Egypt
Site Reference ID/Investigator# 42582
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42593
🇪🇬
Alexandria, Egypt
Site Reference ID/Investigator# 42588
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 29755
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42586
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42595
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42592
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42583
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42587
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42590
🇪🇬
Cairo, Egypt
Site Reference ID/Investigator# 42589
🇪🇬
Cairo, Egypt