Effects of Ketamine on Human Bladders and Its Possible Me... | NCT00957333

Studies
Effects of Ketamine on Human Bladders and Its Possible Mechanisms

NCT00957333

Sponsor

Taipei Medical University WanFang Hospital

Status

Completed

Last Update Posted

Jan 14, 2016Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Cystitis

Interventions

ketamine

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

Participant Flow Module

Pre-assignment Details

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

Nov 2010

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

Mar 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 3, 2009

First Submission Date that Met QC Criteria

Aug 11, 2009

First Posted Date

Aug 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Dec 8, 2015

Results First Submitted that Met QC Criteria

Dec 8, 2015

Results First Posted Date

Jan 14, 2016Estimated

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

Dec 8, 2015

Last Update Posted Date

Jan 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is aimed to evaluate the relationship between ketamine abused and bladder dysfunction and its possible mechanisms.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case		ketamine + Cystitis	Other: ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ketamine	Other		case

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Substance Abuse Situation Record	Substance abuse situation record: ketamine	1 day

Secondary Outcomes

Measure	Description	Time Frame
Urinary Bladder Capacity		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male or female
Cystitis (the clinicians ruled out the causes of bacterial infection)
Frequent micturition
The clinicians are willing to sign the ICF

Exclusion Criteria:

Suffers from the urinary system disease, is not suitable to carry on the urinary bladder biopsy sampling
Suffers from other diseases, doctor recognized that is not suitable to carry on the sampling
The clinicians are not willing to sign the ICF

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruei-Ming Chen, PhD	Taipei Medical University-Wan Fang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University-Wan Fang Hospital		Taipei			Taiwan

ID	Title	Description
FG000	Case	ketamine + Cystitis ketamine

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Case	ketamine + Cystitis ketamine

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Substance Abuse Situation Record

Substance abuse situation record: ketamine

Posted

Mean

Full Range

years

1 day

ID	Title	Description
OG000	Case	ketamine + Cystitis ketamine

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Case	ketamine + Cystitis ketamine

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Ruei-Ming Chen	WanFangH	02-27361661	3222	rmchen@tmu.edu.tw

Condition Browse Module

MeSH Terms

ID	Term
D003556	Cystitis

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided