NCT00957333

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 14, 2016

Completed
Last Updated

January 14, 2016

Status Verified

November 1, 2010

Enrollment Period

9 months

First QC Date

August 3, 2009

Results QC Date

December 8, 2015

Last Update Submit

December 8, 2015

Conditions

Cystitis

Keywords

ketaminebladder dysfunctionbladder mucosamechanisms

Outcome Measures

Primary Outcomes (1)

  • Substance Abuse Situation Record

    Substance abuse situation record: ketamine

    1 day

Secondary Outcomes (1)

  • Urinary Bladder Capacity

    1 day

Study Arms (1)

case

ketamine + Cystitis

Other: ketamine

Interventions

ketamineOTHER
case

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University-Wan Fang Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1.Urine 2.Blood 3.Biopsy

MeSH Terms

Conditions

Cystitis

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Ruei-Ming Chen
Organization
WanFangH
rmchen@tmu.edu.tw
02-27361661

Study Officials

  • Ruei-Ming Chen, PhD

    Taipei Medical University-Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 12, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2011

Last Updated

January 14, 2016

Results First Posted

January 14, 2016

Record last verified: 2010-11

Locations

TW(1)