Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) (SUCRE)
2014年4月14日 更新者：Pfizer
Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
The overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline.
Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson, hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior and during treatment. 5. The incidence and prevalence of valvular fibrosis
調査の概要
詳細な説明
does not involve random selection
研究の種類
観察的
入学 (実際)
22014
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
- 子
- 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
Cohort of patients, who are treated with cabergoline during the study period.
This cohort will be divided in new users and prevalent users based on when cabergoline was started.
New (incident) users will be all persons who have a first prescription for cabergoline after the date that the change in SPC was made.
Prevalent users will be all cohort members who received a cabergoline prescription during the study period but who had also been using cabergoline prior to the change in SPC.
説明
Inclusion Criteria:
- Treated with cabergoline during the study period (January 1st, 2006 and will end on July 1st 2012) and identified in one of 6 databases: The Health Information Network, Health Search Database, Integrated Primary Care Information database, PHARMO, Aarhus hospital databases, and the Universitaet Bremen - Bremen Institute for Prevention
Exclusion Criteria:
- Patients with eligibility dates that start after July 1st 2007 (meaning that they would have less than one year of valid data before publication of the results of the EMEA review), will be excluded as well as patients whose eligibility ends before July 1st 2008 (date of SmPC changes).
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 |
介入・治療 |
|---|---|
|
Cabergoline users
cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)
|
non interventional study - usage as per usual care
|
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 |
|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 1
時間枠：Year 1 (Year 2006)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 1 (Year 2006)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 2
時間枠：Year 2 (Year 2007)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 2 (Year 2007)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 3
時間枠：Year 3 (Year 2008)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 3 (Year 2008)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 4
時間枠：Year 4 (Year 2009)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 4 (Year 2009)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 5
時間枠：Year 5 (Year 2010)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 5 (Year 2010)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 6
時間枠：Year 6 (Year 2011)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 6 (Year 2011)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
時間枠：Year 1 (Year 2006)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 1 (Year 2006)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
時間枠：Year 2 (Year 2007)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 2 (Year 2007)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
時間枠：Year 3 (Year 2008)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 3 (Year 2008)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
時間枠：Year 4 (Year 2009)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 4 (Year 2009)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
時間枠：Year 5 (Year 2010)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 5 (Year 2010)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
時間枠：Year 6 (Year 2011)
|
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 6 (Year 2011)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
時間枠：Year 1 (Year 2006)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 1 (Year 2006)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
時間枠：Year 2 (Year 2007)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 2 (Year 2007)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
時間枠：Year 3 (Year 2008)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 3 (Year 2008)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
時間枠：Year 4 (Year 2009)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 4 (Year 2009)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
時間枠：Year 5 (Year 2010)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 5 (Year 2010)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
時間枠：Year 6 (Year 2011)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 6 (Year 2011)
|
|
Total Number of Echocardiography Examinations in Cabergoline Users
時間枠：Baseline (Week 1) up to Week 339
|
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment.
To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
|
Baseline (Week 1) up to Week 339
|
|
Incidence of Valvular Fibrosis
時間枠：Baseline (Week 1) up to Week 339
|
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment.
Percentage of participants with valvular fibrosis are reported.
|
Baseline (Week 1) up to Week 339
|
|
Prevalence of Valvular Fibrosis
時間枠：Baseline (Week 1) up to Week 339
|
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination.
Percentage of participants with valvular fibrosis are reported.
|
Baseline (Week 1) up to Week 339
|
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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11月1日
一次修了 (実際)
2013年2月1日
研究の完了 (実際)
2013年2月1日
試験登録日
最初に提出
2010年12月9日
QC基準を満たした最初の提出物
2011年1月4日
最初の投稿 (見積もり)
2011年1月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年5月2日
QC基準を満たした最後の更新が送信されました
2014年4月14日
最終確認日
2014年2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。