DRKS00013645
Completed
未知
Acceptability study of a new paediatric formulation of Orphacol® (cholic acid) in paediatric patients treated for inborn errors in primary bile acid synthesis due to 3ß-Hydroxy-?5-C27- steroid oxidoreductase deficiency or ?4-3-Oxosteroid-5ß-reductase deficiency. - ORPH-PAED-01
aboratoires CTRS0 sites4 target enrollmentDecember 22, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- K76.8
- Sponsor
- aboratoires CTRS
- Enrollment
- 4
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females between 5 and 13 years old included.
- •Subject currently treated by Orphacol® commercial capsules or other primary bile acids for inborn errors in primary bile acid synthesis due to 3ß\-Hydroxy\-?5\-C27\-steroid oxidoreductase deficiency or ?4\-3\-Oxosteroid\-5ß\-reductase deficiency.
Exclusion Criteria
- •History of significant or ongoing psychiatric disorder (e.g. severe depression, schizophrenia, psychosis or manic depression).
- •Use of sedatives or antidepressants (including St. John’s Wort).
- •Sensory disorders affecting the mouth or local anaesthetics into the mouth within 48 hours before the study.
- •Previous surgery or radiotherapy for head and neck cancer.
- •Subject who has participated in another study and received any other investigational agent within 30 days prior to start of clinical dosing.
- •Subject and parents/legal representatives unable to provide written informed consent.
- •Failure to satisfy the investigator or eligibility to participate for any other reason.
Outcomes
Primary Outcomes
Not specified
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