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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
観察的
入学 (実際)
519
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Alexandria、エジプト
- Site Reference ID/Investigator# 42584
-
Alexandria、エジプト
- Site Reference ID/Investigator# 42585
-
Alexandria、エジプト
- Site Reference ID/Investigator# 42591
-
Alexandria、エジプト
- Site Reference ID/Investigator# 42593
-
Alexandria、エジプト
- Site Reference ID/Investigator# 42594
-
Cairo、エジプト
- Site Reference ID/Investigator# 29755
-
Cairo、エジプト
- Site Reference ID/Investigator# 42582
-
Cairo、エジプト
- Site Reference ID/Investigator# 42583
-
Cairo、エジプト
- Site Reference ID/Investigator# 42586
-
Cairo、エジプト
- Site Reference ID/Investigator# 42587
-
Cairo、エジプト
- Site Reference ID/Investigator# 42588
-
Cairo、エジプト
- Site Reference ID/Investigator# 42589
-
Cairo、エジプト
- Site Reference ID/Investigator# 42590
-
Cairo、エジプト
- Site Reference ID/Investigator# 42592
-
Cairo、エジプト
- Site Reference ID/Investigator# 42595
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Primary care clinics
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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).
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent of Participant Compliance
時間枠：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
時間枠：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).
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年6月1日
一次修了 (実際)
2010年11月1日
研究の完了 (実際)
2010年11月1日
試験登録日
最初に提出
2010年9月7日
QC基準を満たした最初の提出物
2010年10月20日
最初の投稿 (見積もり)
2010年10月21日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年9月20日
QC基準を満たした最後の更新が送信されました
2013年9月16日
最終確認日
2012年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。