Morning Stiffness, Osteoarthritis, Pain
Conditions
Keywords
Osteoarthritis, Pain, Morning stiffness
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.
Interventions
None listed
Sponsors
Abbott
Clintek
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 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. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 519 |
| Total | 519 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Poor compliance | 1 |
Baseline characteristics
| Characteristic | Brufen Retard |
|---|---|
| Age Continuous | 55 years |
| Region of Enrollment Egypt | 519 participants |
| Sex: Female, Male Female | 348 Participants |
| Sex: Female, Male Male | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 519 |
| serious Total, serious adverse events | 0 / 519 |
Outcome results
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.
Time frame: Baseline and 4 weeks
Population: Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | 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. | 6.12 units on a scale | Standard Deviation 1.38 |
| Brufen Retard (Visit 3, Week 4) | 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. | 2.10 units on a scale | Standard Deviation 1.7 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 4 weeks
Population: Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | 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). | Improved | 516 Participants |
| Brufen Retard Baseline (Visit 1) | 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). | No change | 3 Participants |
| Brufen Retard Baseline (Visit 1) | 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). | Worsened | 0 Participants |
Secondary
Duration of Morning Stiffness
The duration of morning stiffness in minutes was assessed at each visit.
Time frame: Baseline, 2 weeks, and 4 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | Duration of Morning Stiffness | 24.20 minutes | Standard Deviation 15.68 |
| Brufen Retard (Visit 3, Week 4) | Duration of Morning Stiffness | 13.49 minutes | Standard Deviation 11.67 |
| Brufen Retard (All Visits) | Duration of Morning Stiffness | 7.76 minutes | Standard Deviation 9.56 |
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.
Time frame: Baseline to 4 weeks
Population: The tolerability population included all enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | Number of Participants Who Experienced Adverse Events and Serious Adverse Events | Serious adverse events | 0 participants |
| Brufen Retard Baseline (Visit 1) | Number of Participants Who Experienced Adverse Events and Serious Adverse Events | Non-serious adverse events | 41 participants |
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.
Time frame: 2 and 4 weeks
Population: Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | 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). | Improved | 410 Participants |
| Brufen Retard Baseline (Visit 1) | 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). | No change | 109 Participants |
| Brufen Retard Baseline (Visit 1) | 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). | Worsened | 0 Participants |
| Brufen Retard (Visit 3, Week 4) | 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). | Improved | 473 Participants |
| Brufen Retard (Visit 3, Week 4) | 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). | No change | 46 Participants |
| Brufen Retard (Visit 3, Week 4) | 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). | Worsened | 0 Participants |
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.
Time frame: 2 and 4 weeks
Population: Data were analyzed for all participants for which data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | 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) | Achieved 80% reduction in morning stiffness | 58 participants |
| Brufen Retard Baseline (Visit 1) | 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) | Did not achieve 80% reduction morning stiffness | 429 participants |
| Brufen Retard (Visit 3, Week 4) | 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) | Achieved 80% reduction in morning stiffness | 211 participants |
| Brufen Retard (Visit 3, Week 4) | 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) | Did not achieve 80% reduction morning stiffness | 269 participants |
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.
Time frame: Baseline, 2 weeks, and 4 weeks
Population: Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | No joint tenderness/stiffness | 17 participants |
| Brufen Retard Baseline (Visit 1) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Mild joint tenderness/stiffness | 75 participants |
| Brufen Retard Baseline (Visit 1) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Moderate joint tenderness/stiffness | 261 participants |
| Brufen Retard Baseline (Visit 1) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Severe joint tenderness/stiffness | 166 participants |
| Brufen Retard (Visit 3, Week 4) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Severe joint tenderness/stiffness | 5 participants |
| Brufen Retard (Visit 3, Week 4) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | No joint tenderness/stiffness | 87 participants |
| Brufen Retard (Visit 3, Week 4) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Moderate joint tenderness/stiffness | 156 participants |
| Brufen Retard (Visit 3, Week 4) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Mild joint tenderness/stiffness | 271 participants |
| Brufen Retard (All Visits) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Severe joint tenderness/stiffness | 3 participants |
| Brufen Retard (All Visits) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Mild joint tenderness/stiffness | 210 participants |
| Brufen Retard (All Visits) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | Moderate joint tenderness/stiffness | 44 participants |
| Brufen Retard (All Visits) | Number of Participants With Joint Tenderness/Stiffness at Each Visit | No joint tenderness/stiffness | 262 participants |
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.
Time frame: Baseline, 2 weeks, and 4 weeks
Population: Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | Number of Participants With the Ability to Carry Out Normal Activities at Each Visit | Yes | 172 participants |
| Brufen Retard Baseline (Visit 1) | Number of Participants With the Ability to Carry Out Normal Activities at Each Visit | No | 347 participants |
| Brufen Retard (Visit 3, Week 4) | Number of Participants With the Ability to Carry Out Normal Activities at Each Visit | Yes | 381 participants |
| Brufen Retard (Visit 3, Week 4) | Number of Participants With the Ability to Carry Out Normal Activities at Each Visit | No | 138 participants |
| Brufen Retard (All Visits) | Number of Participants With the Ability to Carry Out Normal Activities at Each Visit | Yes | 471 participants |
| Brufen Retard (All Visits) | Number of Participants With the Ability to Carry Out Normal Activities at Each Visit | No | 48 participants |
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).
Time frame: 2 and 4 weeks
Population: Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Brufen Retard Baseline (Visit 1) | Percent of Participant Compliance | 99.39 percentage of participant compliance | 0.99 |
| Brufen Retard (Visit 3, Week 4) | Percent of Participant Compliance | 97.71 percentage of participant compliance | 2.41 |
| Brufen Retard (All Visits) | Percent of Participant Compliance | 98.55 percentage of participant compliance | 1.86 |