Pharmacokinetics and Safety Studies of Esomeprazole Use i... | NCT03333603

Studies
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

NCT03333603

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Mar 29, 2018Actual

Enrollment

25Actual

Phase

Phase 4

Conditions

Schizophrenia

Interventions

esomeprazole

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2016Actual

Primary Completion Date

Jan 23, 2017Actual

Completion Date

Jan 23, 2017Actual

First Submitted Date

Jan 17, 2017

First Submission Date that Met QC Criteria

Nov 2, 2017

First Posted Date

Nov 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2018

Last Update Posted Date

Mar 29, 2018Actual

Name	Class
National Taiwan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
esomeprazole	Experimental	esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56	Drug: esomeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
esomeprazole	Drug	esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56	esomeprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma Concentration analysis	The pharmacokinetic parameters for esomeprazole and its main metabolites	It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose

Secondary Outcomes

Measure	Description	Time Frame
CYP2C19 genotypes analysis	Investigators will genotype CYP2C19 genotype to determine that which metabolized type (poor metabolizer, intermediate metabolizer, and good metabolizer) of patients belong to.	The genotype will be assessed on Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

20-65 years old
Diagnosed as DSM-IV schizophrenia
No adjustment of dose of major antipsychotics for at least 4 weeks
Competence for inform consent

Exclusion criteria

Diagnosed with schizoaffective disorder or bipolar affective disorder or organic psychotic disorder
Meet the diagnostic criteria of any substance abuse or dependence in the past 6 months
History or evidence of any clinically significant medical or neurological disease, such as autoimmune disease, cancer, epilepsy, etc.
Mental retardation or pervasive developmental disorders
Past history of allergy to Esomeprazole
patient who is taking clozapine、 Depakin or Diazepam
Pregnant
The patient is under the order of involuntary admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chih-Min Liu	Visiting Staff	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		10048	Taiwan
National Taiwan University Hospital Yunlin Branch

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064098	Esomeprazole

Ancestor Terms

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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 esomeprazoleon Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.