Clinical trial NCT01757470: Vandetanib Risk Minimisation Effectiveness
Official title: Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medullary Thyroid Cancer
Keywords: effectiveness of risk mitigation,
knowledge and understanding survey,
drug utilisation study,
post marketing commitments
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample for patients and physicians

Brief summary: Effectiveness of risk minimisation interventions for vandetanib in Canada

Detailed description: As part of the new drug approval process in Canada, AstraZeneca has committed to Health Canada to conduct a Drug Utilization Study among patients recently treated with CAPRELSA (vandetanib) and a Knowledge and Understanding Survey among the prescribing physicians to determine whether the product monograph, communication plan, and educational material developed by AstraZeneca Canada for vandetanib are adequate to provide knowledge about the potential risks associated with this product, and if other medications taken concomitantly with vandetanib are managed adequately.

Eligibility criteria: Inclusion Criteria:

- N/A (all patients taking Caprelsa and all prescribers will be contacted for participation).

Exclusion Criteria: - N/A

Primary outcomes:
measure: Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib
timeFrame: 2 months
measure: Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline
timeFrame: At baseline
measure: Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months
timeFrame: At 3 months
measure: Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months
timeFrame: At 6 months
measure: Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months
timeFrame: At 12 months
measure: Drug Utilisation Study: Use of vandetanib - dosage at baseline
timeFrame: At baseline
measure: Drug Utilisation Study: Use of vandetanib - dosage at 3 months
timeFrame: At 3 months
measure: Drug Utilisation Study: Use of vandetanib - dosage at 6 months
timeFrame: At 6 months
measure: Drug Utilisation Study: Use of vandetanib - dosage at 12 months
timeFrame: At 12 months
measure: Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline
timeFrame: At baseline
measure: Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months
timeFrame: At 3 months
measure: Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months
timeFrame: At 6 months
measure: Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months
timeFrame: At 12 months
Secondary outcomes:
measure: Knowledge and Understanding Survey: Practice characteristics
timeFrame: 2 months
measure: Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training
timeFrame: 2 months
measure: Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib
timeFrame: 2 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Research Site
state: Quebec
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: