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

2013年9月16日 更新者：Abbott

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

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

519

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 埃及
      • Alexandria、埃及
        • Site Reference ID/Investigator# 42584
      • Alexandria、埃及
        • Site Reference ID/Investigator# 42585
      • Alexandria、埃及
        • Site Reference ID/Investigator# 42591
      • Alexandria、埃及
        • Site Reference ID/Investigator# 42593
      • Alexandria、埃及
        • Site Reference ID/Investigator# 42594
      • Cairo、埃及
        • Site Reference ID/Investigator# 29755
      • Cairo、埃及
        • Site Reference ID/Investigator# 42582
      • Cairo、埃及
        • Site Reference ID/Investigator# 42583
      • Cairo、埃及
        • Site Reference ID/Investigator# 42586
      • Cairo、埃及
        • Site Reference ID/Investigator# 42587
      • Cairo、埃及
        • Site Reference ID/Investigator# 42588
      • Cairo、埃及
        • Site Reference ID/Investigator# 42589
      • Cairo、埃及
        • Site Reference ID/Investigator# 42590
      • Cairo、埃及
        • Site Reference ID/Investigator# 42592
      • Cairo、埃及
        • Site Reference ID/Investigator# 42595

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Primary care clinics

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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.
大体时间：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.
Baseline and 4 weeks
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).
大体时间：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.
4 weeks

次要结果测量

结果测量
措施说明
大体时间
Percent of Participant Compliance
大体时间：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).
2 and 4 weeks
Number of Participants With Joint Tenderness/Stiffness at Each Visit
大体时间：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.
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).
大体时间：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.
2 and 4 weeks
Duration of Morning Stiffness
大体时间：Baseline, 2 weeks, and 4 weeks
The duration of morning stiffness in minutes was assessed at each visit.
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)
大体时间：2 and 4 weeks
The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
2 and 4 weeks
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
大体时间：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.
Baseline, 2 weeks, and 4 weeks
Number of Participants Who Experienced Adverse Events and Serious Adverse Events
大体时间：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.
Baseline to 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Abbott

合作者

Clintek

调查人员

  • 研究主任：Rasha Eldessouky, MBBC、Abbott (Egypt)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年6月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2010年9月7日

首先提交符合 QC 标准的

2010年10月20日

首次发布 (估计)

2010年10月21日

研究记录更新

最后更新发布 (估计)

2013年9月20日

上次提交的符合 QC 标准的更新

2013年9月16日

最后验证

2012年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • P12-162

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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