UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008757 |
|---|---|
| Receipt number | R000009424 |
| Scientific Title | 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 | 2019/02/04 15:19:59 |
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Basic information
Public title
Analysis of the effect of tricyclic antidepressants for herpes zoster pain or post herpetic neuralgia for the QTc interval on electrocardiogram.
Acronym
Analysis of the effect of tricyclic antidepressants for analgesic adjuvant on the QTc interval.
Scientific Title
Analysis of the effect of tricyclic antidepressants for herpes zoster pain or post herpetic neuralgia for the QTc interval on electrocardiogram.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomoharu Funao |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
1-5-7, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-2186
yusuke.funai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Funai |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
1-5-7, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-2186
Homepage URL
yusuke.funai@gmail.com
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 05 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009424
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