Primary Outcome Measures:
- 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. [ Time Frame: 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). [ Time Frame: 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:
- Percent of Participant Compliance [ Time Frame: 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 [ Time Frame: 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). [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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.