Taste and palatability of Orfadin suspension

• Research type

  Research Study

• Full title

  Taste and palatability of Orfadin suspension. An open, non-controlled 3-day study in pediatric patients with hereditary tyrosinemia type 1 treated with Orfadin.

• IRAS ID

  112229

• Contact name

  Patrick McKiernan

• Sponsor organisation

  Swedish Orphan Biovitrum AB

• Eudract number

  2012-002286-36

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study will assess the taste and palability of a new liquid formula of a nitisone currently only available in capsules. Young children find it difficult to swallow capsules and the capsules are broken open and mixed with food, this could result in patient not receiving correct dose. The new suspension will ensure that the patients who cannot swallow capsules will receive the correct dose to treat their condition.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  12/NE/0286

• Date of REC Opinion

  4 Oct 2012

• REC opinion

  Further Information Favourable Opinion