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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 519
- 试验地点
- 15
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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).
时间窗: 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.
次要结局
- Percent of Participant Compliance(2 and 4 weeks)
- Number of Participants With Joint Tenderness/Stiffness at Each Visit(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).(2 and 4 weeks)
- Duration of Morning Stiffness(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)(2 and 4 weeks)
- Number of Participants With the Ability to Carry Out Normal Activities at Each Visit(Baseline, 2 weeks, and 4 weeks)
- Number of Participants Who Experienced Adverse Events and Serious Adverse Events(Baseline to 4 weeks)