UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026441 |
|---|---|
| Receipt number | R000030381 |
| Scientific Title | Comparative test on the occurrence rate of side effects accompanying duloxetine oral dosing timing |
| Date of disclosure of the study information | 2017/04/15 |
| Last modified on | 2017/03/14 10:52:01 |
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Basic information
Public title
Comparative test on the occurrence rate of side effects accompanying duloxetine oral dosing timing
Acronym
Study on the incidence of adverse reactions due to internal timing of duloxetine
Scientific Title
Comparative test on the occurrence rate of side effects accompanying duloxetine oral dosing timing
Scientific Title:Acronym
Study on the incidence of adverse reactions due to internal timing of duloxetine
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of side effects in the internal timing of duloxetine
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of side effects within 4 weeks after starting oral administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral intake of duloxetine after breakfast
Interventions/Control_2
Oral intake of duloxetine befor sleep
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
| 26 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients with pain of 1 month or more
2 Patients over 26 years of age
3 Document consent has been obtained from the patient himself or his substitute.
Key exclusion criteria
1 Patients under 25 years of age
2 A patient with suicide ideas and suicide attempts in the past
3 Patients with a history of hypersensitivity to the ingredients of this drug
4 Patients during monoamine oxidase inhibitor administration or within 2 weeks after discontinuation of administration
5 Patients with high liver damage or advanced renal impairment
6 Patient with poor control of closed angle glaucoma
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Fukazawa |
Organization
Saku Central Hospital
Division name
Pain Clinic
Zip code
Address
Usuda 197 Saku, Nagano 384-0301 Japan
TEL
0267823131
mame197931@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Niimi |
Organization
Saku Central Hospital
Division name
Clinical research and study center
Zip code
Address
Usuda 197 Saku, Nagano 384-0301 Japan
TEL
0267823131
Homepage URL
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2017 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030381
