Study identification

EU PAS number

EUPAS103748

Study ID

103749

Official title and acronym

Effectiveness of the Mysimba Physician Prescribing Checklist (PPC): Focus group to assess understanding, attitude, and behaviour for usage of the PPC and for key safety messages (NB-453 PPC focus groups)

DARWIN EU® study

No

Study countries

Czechia
Greece
Norway

Study description

This is a follow-up study to the NB-452 Physician Prescribing Checklist (PPC) survey study in which 71.3% (95%CI 64.9%, 77.1%) of Mysimba prescribers met the overall knowledge and understanding (KAU) criteria (primary outcome), which did not reach the pre-specified threshold of 85% for effectiveness of the PPC. Prior to developing a strategy for improving the awareness, usage and understanding of the Mysimba PPC, or making any modification to the risk minimisation strategy, it is necessary to conduct a root cause analysis of low awareness of the PPC as well as of incorrect responses to survey questions related to knowledge and understanding of selected key safety messages. This focus group study will be conducted to help determine the adequacy of the Mysimba PPC, and potentially guide strategies to improve the understanding of key safety messages described in the EU RMP for Mysimba.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Michael Kyle

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Orexigen Therapeutics/Currax Pharmaceuticals LLC
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)