UMIN-CTR Clinical Trial

Basic information
Public title	Study to evaluate what patients basline factors affect placebo effect in patients with insomnia
Acronym	Study to evaluate what patients basline factors affect placebo effect in patients with insomnia
Scientific Title	Study to evaluate what patients basline factors affect placebo effect in patients with insomnia
Scientific Title:Acronym	Study to evaluate what patients basline factors affect placebo effect in patients with insomnia
Region	Japan

Condition
Condition	Insomnia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine what patients' baseline factors affect the placebo effect using the database for placebo groups of a clinical study in patients with insomnia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in subjective sleep latency
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Placebo (the database only from placebo groups will be used for the current study)
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	All the patients randominzed in placebo group in the clinical study in patients with primary insomnia
Key exclusion criteria	Patients who were not included in FAS were excluded
Target sample size	380

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koji Kawakami
Organization	Graduate School of Medicine and Public Health, Kyoto University
Division name	Department of Pharmacoepidemiology
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku Kyoto 606-8501, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Atsushi Ogawa
Organization	Graduate School of Medicine and Public Health, Kyoto University
Division name	Department of Pharmacoepidemiology
Zip code
Address
TEL
Homepage URL
Email	ogawa.atsushi@fx7.ecs.kyoto-u.ac.jp

Sponsor
Institute	Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

Funding Source
Organization	None
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
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	2010 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.sciencedirect.com/science/article/pii/S1389945711001250
Number of participants that the trial has enrolled
Results	Ogawa A, Hinotsu S, Urushihara H, Kawakami K. Night-to-night variability of sleep latency significantly predicts the magnitude of subsequent change in sleep latency during placebo administration. Sleep Med 2011;6:565-571
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	2010 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2011 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 06 Month 18 Day
Last modified on	2011 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004573

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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