PDS290 Focused Usability Test of colour-blind individuals’ ability to differentiate between Tresiba® 100 units/mL FlexTouch®, Tresiba® 200 units/mL FlexTouch®, and NovoRapid® FlexPen® pen-injectors and cartons

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15966
• EU PAS number:
  EUPAS4122
• Study ID:
  15966
• Official title and acronym:
  PDS290 Focused Usability Test of colour-blind individuals’ ability to differentiate between Tresiba® 100 units/mL FlexTouch®, Tresiba® 200 units/mL FlexTouch®, and NovoRapid® FlexPen® pen-injectors and cartons
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  United Kingdom
• Study description:
  The test objective is to investigate whether people suffering from red-green colour-blindness can differentiate between different pen-injectors and their respective packages (i.e., cartons).
• Study status:
  Finalised

Research institutions and networks

Institutions

Novo Nordisk

Multiple centres: 10 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 29/07/2013

Study start date

Actual: 02/05/2014

Data analysis start date

Actual: 22/05/2014

Date of final study report

Actual: 18/08/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

UT117-test-protocol-final-version-2-12-dec-2013-Redacted

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)