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.
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.
Study Type
OBSERVATIONAL
Enrollment
519
Site Reference ID/Investigator# 42584
Alexandria, Egypt
Site Reference ID/Investigator# 42585
Alexandria, Egypt
Site Reference ID/Investigator# 42591
Alexandria, Egypt
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.
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.
Time frame: Baseline and 4 weeks
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).
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.
Time frame: 4 weeks
Percent of Participant Compliance
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).
Time frame: 2 and 4 weeks
Number of Participants With Joint Tenderness/Stiffness at Each Visit
Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
Time frame: Baseline, 2 weeks, and 4 weeks
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).
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Site Reference ID/Investigator# 42593
Alexandria, Egypt
Site Reference ID/Investigator# 42594
Alexandria, Egypt
Site Reference ID/Investigator# 29755
Cairo, Egypt
Site Reference ID/Investigator# 42582
Cairo, Egypt
Site Reference ID/Investigator# 42583
Cairo, Egypt
Site Reference ID/Investigator# 42586
Cairo, Egypt
Site Reference ID/Investigator# 42587
Cairo, Egypt
...and 5 more locations
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.
Time frame: 2 and 4 weeks
Duration of Morning Stiffness
The duration of morning stiffness in minutes was assessed at each visit.
Time frame: Baseline, 2 weeks, and 4 weeks
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)
The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
Time frame: 2 and 4 weeks
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
The number of participants who were able or unable to carry out normal activities was assessed at each visit.
Time frame: Baseline, 2 weeks, and 4 weeks
Number of Participants Who Experienced Adverse Events and Serious Adverse Events
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.
Time frame: Baseline to 4 weeks