CompletedPhase 1

Taste and Palatability of Orfadin Suspension

France, Germany, United Kingdom18 participantsStarted 2012-10

Plain-language summary

The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

Who can participate

Age range1 Month – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with HT-1 currently managed on Orfadin (nitisinone) capsules. * Age from 1 month to less than 18 years. * Signed informed consent. Exclusion Criteria: * Any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion. * Enrollment in another concurrent clinical study, or intake of an investigational medicinal product (IMP), within one month prior to inclusion in this study. * Foreseeable inability to cooperate with given instructions or study procedures.

What they're measuring

The Taste Score for the Last Dose of the Suspension on Day 3 for Subjects 5 - <18 Years

Timeframe: Day 3

The Acceptability Score for the Last Dose of the Suspension on Day 3 for Subjects < 5 Years

Timeframe: Day 3

Trial details

NCT IDNCT01734889

SponsorSwedish Orphan Biovitrum

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03

Results submitted2014-01-21

View on ClinicalTrials.gov More Hereditary Tyrosinemia, Type I trials