XPhe minis Market Research_V1

• Research type

  Research Study

• Full title

  XPhe minis - Acceptability and Tolerance Market Research

• IRAS ID

  279748

• Contact name

  Yvonne Muecke

• Contact email

  yvonne.muecke@metax.org

• Sponsor organisation

  metaX Institut fuer Diatetik GmbH

• Clinicaltrials.gov Identifier

  NCT04375592

• Duration of Study in the UK

  0 years, 6 months, 31 days

• Research summary

  This is a prospective, observational market research study in 10 children with PHENYLKETONURIA. Subjects who are currently taking a phenylalanine-free protein substitute will be recruited for a 7-day trial of the new ready-to-use protein substitute tablets to evaluate the tolerability and acceptability of the study product. The outcome of this assessment will be used in a submission to regulatory authorities to get the study product reimbursable on prescription in the UK.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  20/WM/0154

• Date of REC Opinion

  3 Aug 2020

• REC opinion

  Further Information Favourable Opinion