Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT03333603
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia
Detailed Description:
Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: