Trial Outcomes & Findings for Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients (NCT NCT01226095)

NCT ID: NCT01226095

Last Updated: 2013-09-20

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 519 participants
• Primary outcome timeframe: Baseline and 4 weeks
• Results posted on: 2013-09-20

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	519
Overall Study COMPLETED	518
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Poor compliance	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Brufen Retard n=519 Participants 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.
Age Continuous	55 years n=5 Participants
Sex: Female, Male Female	348 Participants n=5 Participants
Sex: Female, Male Male	171 Participants n=5 Participants
Region of Enrollment Egypt	519 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=519 Participants 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.	Brufen Retard (Visit 3, Week 4) n=519 Participants 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.	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.
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	2.10 units on a scale Standard Deviation 1.70	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=519 Participants 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.	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.	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.
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	—	—
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	—	—
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 outcome

Timeframe: 2 and 4 weeks

Population: Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken.

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).

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=519 Participants 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.	Brufen Retard (Visit 3, Week 4) n=519 Participants 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.	Brufen Retard (All Visits) n=519 Participants 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.
Percent of Participant Compliance	99.39 percentage of participant compliance 0.99	97.71 percentage of participant compliance 2.41	98.55 percentage of participant compliance 1.86

SECONDARY outcome

Timeframe: 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.

Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=519 Participants 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.	Brufen Retard (Visit 3, Week 4) n=519 Participants 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.	Brufen Retard (All Visits) n=519 Participants 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.
Number of Participants With Joint Tenderness/Stiffness at Each Visit No joint tenderness/stiffness	17 participants	87 participants	262 participants
Number of Participants With Joint Tenderness/Stiffness at Each Visit Mild joint tenderness/stiffness	75 participants	271 participants	210 participants
Number of Participants With Joint Tenderness/Stiffness at Each Visit Moderate joint tenderness/stiffness	261 participants	156 participants	44 participants
Number of Participants With Joint Tenderness/Stiffness at Each Visit Severe joint tenderness/stiffness	166 participants	5 participants	3 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=519 Participants 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.	Brufen Retard (Visit 3, Week 4) n=519 Participants 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.	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.
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	473 Participants	—
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	46 Participants	—
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	0 Participants	—

SECONDARY outcome

Timeframe: 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.

The duration of morning stiffness in minutes was assessed at each visit.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=493 Participants 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.	Brufen Retard (Visit 3, Week 4) n=487 Participants 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.	Brufen Retard (All Visits) n=480 Participants 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.
Duration of Morning Stiffness	24.20 minutes Standard Deviation 15.68	13.49 minutes Standard Deviation 11.67	7.76 minutes Standard Deviation 9.56

SECONDARY outcome

Timeframe: 2 and 4 weeks

Population: Data were analyzed for all participants for which data were available.

The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=487 Participants 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.	Brufen Retard (Visit 3, Week 4) n=480 Participants 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.	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.
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	211 participants	—
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	269 participants	—

SECONDARY outcome

Timeframe: 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.

The number of participants who were able or unable to carry out normal activities was assessed at each visit.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=519 Participants 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.	Brufen Retard (Visit 3, Week 4) n=519 Participants 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.	Brufen Retard (All Visits) n=519 Participants 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.
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit Yes	172 participants	381 participants	471 participants
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit No	347 participants	138 participants	48 participants

SECONDARY outcome

Timeframe: Baseline to 4 weeks

Population: The tolerability population included all enrolled participants.

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.

Outcome measures

Measure	Brufen Retard Baseline (Visit 1) n=519 Participants 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.	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.	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.
Number of Participants Who Experienced Adverse Events and Serious Adverse Events Serious adverse events	0 participants	—	—
Number of Participants Who Experienced Adverse Events and Serious Adverse Events Non-serious adverse events	41 participants	—	—

Adverse Events

Brufen Retard

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Brufen Retard n=519 participants at risk 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.
Gastrointestinal disorders Abdominal discomfort	0.58% 3/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Abdominal pain	0.39% 2/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Abdominal pain upper	0.58% 3/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Diarrhoea	0.39% 2/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Dyspepsia	1.2% 6/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Gastritis	3.9% 20/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Gastrointestinal pain	0.19% 1/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Nausea	0.77% 4/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Reflux oesophagitis	0.39% 2/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Gastrointestinal disorders Vomiting	0.19% 1/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
General disorders Oedema peripheral	0.19% 1/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Nervous system disorders Headache	0.39% 2/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Skin and subcutaneous tissue disorders Pruritus	0.19% 1/519 • All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.

Additional Information

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