| Primary | 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. | Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
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| OG000 | Brufen Retard Baseline (Visit 1) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information. | | OG001 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG0006.12± 1.38
- OG0012.10± 1.70
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | <0.0001 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
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| Secondary | 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). | Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken. | Posted | | Number | | percentage of participant compliance | | 2 and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard (Visit 2, Week 2) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks. | | OG001 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. | | OG002 | Brufen Retard (All Visits) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information throughout this post-marketing observational study. |
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| Secondary | 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. | Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants. | Posted | | Number | | participants | | Baseline, 2 weeks, and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard Baseline (Visit 1) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information. | | OG001 | Brufen Retard (Visit 2, Week 2) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks. | | OG002 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
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| Secondary | 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). | 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. | Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants. | Posted | | Number | | Participants | | 2 and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard (Visit 2, Week 2) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks. | | OG001 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
| |
| Secondary | Duration of Morning Stiffness | The duration of morning stiffness in minutes was assessed at each visit. | Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, however, only participants with available morning stiffness data were included in the analysis for each visit. | Posted | | Mean | Standard Deviation | minutes | | Baseline, 2 weeks, and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard Baseline (Visit 1) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information. | | OG001 | Brufen Retard (Visit 2, Week 2) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks. | | OG002 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
|
| Primary | 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. | Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants. | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
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| Secondary | 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. | Data were analyzed for all participants for which data were available. | Posted | | Number | | participants | | 2 and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard (Visit 2, Week 2) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks. | | OG001 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
| |
| Secondary | 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. | Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants. | Posted | | Number | | participants | | Baseline, 2 weeks, and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard Baseline (Visit 1) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information. | | OG001 | Brufen Retard (Visit 2, Week 2) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks. | | OG002 | Brufen Retard (Visit 3, Week 4) | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
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| Secondary | 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. | The tolerability population included all enrolled participants. | Posted | | Number | | participants | | Baseline to 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Brufen Retard | Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. |
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