Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
2013년 9월 16일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
관찰
등록 (실제)
519
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alexandria, 이집트
- Site Reference ID/Investigator# 42584
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Alexandria, 이집트
- Site Reference ID/Investigator# 42585
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Alexandria, 이집트
- Site Reference ID/Investigator# 42591
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Alexandria, 이집트
- Site Reference ID/Investigator# 42593
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Alexandria, 이집트
- Site Reference ID/Investigator# 42594
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Cairo, 이집트
- Site Reference ID/Investigator# 29755
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Cairo, 이집트
- Site Reference ID/Investigator# 42582
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Cairo, 이집트
- Site Reference ID/Investigator# 42583
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Cairo, 이집트
- Site Reference ID/Investigator# 42586
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Cairo, 이집트
- Site Reference ID/Investigator# 42587
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Cairo, 이집트
- Site Reference ID/Investigator# 42588
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Cairo, 이집트
- Site Reference ID/Investigator# 42589
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Cairo, 이집트
- Site Reference ID/Investigator# 42590
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Cairo, 이집트
- Site Reference ID/Investigator# 42592
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Cairo, 이집트
- Site Reference ID/Investigator# 42595
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Primary care clinics
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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.
기간: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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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).
기간: 4 weeks
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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.
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4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percent of Participant Compliance
기간: 2 and 4 weeks
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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).
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2 and 4 weeks
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Number of Participants With Joint Tenderness/Stiffness at Each Visit
기간: Baseline, 2 weeks, and 4 weeks
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Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
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Baseline, 2 weeks, and 4 weeks
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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).
기간: 2 and 4 weeks
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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.
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2 and 4 weeks
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Duration of Morning Stiffness
기간: Baseline, 2 weeks, and 4 weeks
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The duration of morning stiffness in minutes was assessed at each visit.
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Baseline, 2 weeks, and 4 weeks
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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)
기간: 2 and 4 weeks
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The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
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2 and 4 weeks
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Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
기간: Baseline, 2 weeks, and 4 weeks
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The number of participants who were able or unable to carry out normal activities was assessed at each visit.
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Baseline, 2 weeks, and 4 weeks
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Number of Participants Who Experienced Adverse Events and Serious Adverse Events
기간: Baseline to 4 weeks
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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.
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Baseline to 4 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 6월 1일
기본 완료 (실제)
2010년 11월 1일
연구 완료 (실제)
2010년 11월 1일
연구 등록 날짜
최초 제출
2010년 9월 7일
QC 기준을 충족하는 최초 제출
2010년 10월 20일
처음 게시됨 (추정)
2010년 10월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 9월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 9월 16일
마지막으로 확인됨
2012년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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