UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000008757
Receipt No. R000009424
Official scientific title of the study Analysis of the effect of tricyclic antidepressants for herpes zoster pain or post herpetic neuralgia for the QTc interval on electrocardiogram.
Date of disclosure of the study information 2012/08/23
Last modified on 2013/08/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Analysis of the effect of tricyclic antidepressants for herpes zoster pain or post herpetic neuralgia for the QTc interval on electrocardiogram.
Title of the study (Brief title) Analysis of the effect of tricyclic antidepressants for analgesic adjuvant on the QTc interval.
Region
Japan

Condition
Condition herpes zoster pain, post herpetic neuralgia
Classification by specialty
Medicine in general Infectious disease Dermatology
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety on the electrocardiogram for administering tricyclic antidepressants as analgesic adjuvant.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes QTc interval before and after the administration of TCAs.
Key secondary outcomes age, gender, the type and dose of administered TCAs, medication periods

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were administered TCAs for herpes zoster pain or post herpetic neuralgia between May 2007 and January 2012, and who have electrocardiogram before and after the medication.
Key exclusion criteria Patients who were administered other antipsychotic or anti-arrhythmic agents, and who have any rhythm disturbance on the electrocardiogram (ECG) before medication.
Target sample size 100

Research contact person
Name of lead principal investigator Tomoharu Funao
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Address 1-5-7, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-2186
Email

Public contact
Name of contact person Yusuke Funai
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Address 1-5-7, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-2186
Homepage URL
Email yusuke.funai@gmail.com

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市立大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 23 Day

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 05 Month 01 Day
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2012 Year 12 Month 31 Day
Date analysis concluded
2013 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results Eighty-seven patients were analysed. The analgesic dosages of TCAs significantly prolonged QTc interval(delta QTc, 6.7 +- 16.1 ms). Although 15 patients were categorized as having abnormal QTc prolongation, there were no dangerous cases such as QTc > 500 ms or delta QTc > 60 ms. In multivariate logistic analysis, Left ventricular hypertrophy was detected as independent risk factor for abnormal QTc prolongation (OR 4.09; 95% CI 1.01-16.55, p=0.04).
Other related information This study is retrospective observational study. All data are collected retrospectively from the electronic medical chart in our hospitals. Age, gender, the type of TCAs, daily dosages, and the period between the start of medication and the second ECG recording as medication period are extracted.Paired t test or Wilcoxon singed rank test is used for the comparison of b-QTc and a-QTc. For detecting the risk factor of the QTc prolongation, multivariate analysis is performed.

Management information
Registered date
2012 Year 08 Month 23 Day
Last modified on
2013 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009424


Contact us.