NCT01734889

Taste and Palatability of Orfadin Suspension

Taste and Palatability of Orfadin Suspension. An Open, Non-controlled 3 Day Study in Pediatric Patients With Hereditary Tyrosinemia Type 1 Treated With Orfadin.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open, non-randomized, non-controlled, multiple-dose study in 18 pediatric patients. The treatment period is three days, and during the study the subjects will rate the taste and palatability of the suspension or (for younger children) their parents will rate the child´s acceptance of the suspension. The study consists of a screening period, a 3 day treatment period and a 1 week follow-up period.

Conditions

• Hereditary Tyrosinemia, Type I

Interventions

Type	Name	Description
DRUG	Nitisinone	Oral suspension

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-11-28
• Last updated: 2014-11-06
• Results posted: 2014-03-04

Locations

7 sites across 3 countries: France, Germany, United Kingdom