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Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) (SUCRE)

14 april 2014 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

does not involve random selection

Studietyp

Observationell

Inskrivning (Faktisk)

22014

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Cabergoline users
cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)
Läkemedel: Study Drug
non interventional study - usage as per usual care

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Cabergoline Prescriptions by Database and Indication: Year 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

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Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2010

Primärt slutförande (Faktisk)

1 februari 2013

Avslutad studie (Faktisk)

1 februari 2013

Studieregistreringsdatum

Först inskickad

9 december 2010

Först inskickad som uppfyllde QC-kriterierna

4 januari 2011

Första postat (Uppskatta)

5 januari 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

2 maj 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 april 2014

Senast verifierad

1 februari 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A7231030

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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