Last updated: 02/26/2019 14:00:19
Quantitative Testing of Prescriber Knowledge about TANZEUMTM (albiglutide) Safety and Use Information
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Quantitative Testing of Prescriber Knowledge about TANZEUMTM (albiglutide) Safety and Use Information
Trial description: This is a survey designed to assess prescribers’ knowledge regarding the risks and safe use of albiglutide (TANZEUM, it is a trademark owned by GlaxoSmithKline [GSK]). The results of this survey together with other Risk Evaluation and Mitigation Strategy (REMS) evaluation metrics, will be used to determine the effectiveness of the REMS in mitigating the risks of albiglutide. This data will also be used to assess if changes are needed to the REMS materials to make them more effective in achieving the goal of the REMS. The survey will be implemented in 3 parts, known as waves, so that data will be available for inclusion in the REMS assessment reports submitted to the Food and Drug Administration (FDA) at 18 months (Wave 1), 3 years (Wave 2), and 7 years (Wave 3) from the date of albiglutide REMS approval.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of prescriber having knowledge of potential risk of medullary thyroid carcinoma (MTC) with use of albiglutide
Timeframe: Up to 7 years
Number of prescriber having knowledge on risk of acute pancreatitis with use of albiglutide
Timeframe: Up to 7 years
Number of prescriber having knowledge on evaluation of patients who develop symptoms suggestive of pancreatitis after use of albiglutide
Timeframe: Up to 7 years
Number of prescriber having knowledge of prescriber on characteristics of the appropriate patient population for which TANZEUM should be prescribed with use of albiglutide
Timeframe: Up to 7 years
Secondary outcomes:
Not applicable
Interventions:
Other: Questionnaire administration
Enrollment:
1
Observational study model:
Other
Primary completion date:
2017-30-03
Time perspective:
Prospective
Clinical publications:
Carol Koro, Janet Pientka, Veronica Bainbridge, Natalie O’Donnell, Monika Stender, Annette Stemhagen. Quantitative Testing of Prescriber Knowledge Regarding the Risks and Safe Use of Albiglutide. Drugs Real World Outcomes. 2018;5(1):55-67.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
United Biosource Corporation (UBC)
Study date(s)
November 2016 to March 2017
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
Yes
- For Wave 1 only, HCPs who have prescribed albiglutide at least once
- For Wave 2 and Wave 3 surveys, HCPs who have prescribed albiglutide at least once in the previous 12 months
- HCPs who have ever worked for or whose immediate family members have ever worked for GSK, United BioSource Corporation (UBC), or the FDA
- For Wave 2 and Wave 3 surveys, HCPs who have participated in Qualitative Research (QR) or who have participated in a previous albiglutide knowledge survey
Inclusion and exclusion criteria
Inclusion criteria:
- For Wave 1 only, HCPs who have prescribed albiglutide at least once
- For Wave 2 and Wave 3 surveys, HCPs who have prescribed albiglutide at least once in the previous 12 months
Exclusion criteria:
- HCPs who have ever worked for or whose immediate family members have ever worked for GSK, United BioSource Corporation (UBC), or the FDA
- For Wave 2 and Wave 3 surveys, HCPs who have participated in Qualitative Research (QR) or who have participated in a previous albiglutide knowledge survey
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2017-30-03
Actual study completion date
2017-30-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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