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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026441
Receipt No. 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

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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
Email 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
Email ctroffice@sakuhp.or.jp

Sponsor
Institute Saku Central Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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