UMIN-CTR Clinical Trial

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

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

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	yusuke.funai@gmail.com

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

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	Published
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	2019 Year 02 Month 04 Day

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