UMIN-CTR Clinical Trial

Basic information
Public title	Questionnaire survey about peripheral neuropaty with HIV infected patients
Acronym	Questionnaire survey about peripheral neuropaty with HIV infected patients
Scientific Title	Questionnaire survey about peripheral neuropaty with HIV infected patients
Scientific Title:Acronym	Questionnaire survey about peripheral neuropaty with HIV infected patients
Region	Japan

Condition
Condition	HIV/AIDS
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate symptoms and treatments associated peripheral neuropathy in HIV-infected patients
Basic objectives2	Others
Basic objectives -Others	To investigate symptoms and treatments associated peripheral neuropathy in HIV-infected patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of pain in HIV-infected patients
Key secondary outcomes

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	20 years-old <=
Age-upper limit	95 years-old >
Gender	Male and Female
Key inclusion criteria	HIV-infected patients
Key exclusion criteria	N/A
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Megumi Middle name Last name Kanda
Organization	Asahikawa medical university
Division name	Anesthesiology & Critical Care Medicine
Zip code	0788510
Address	Midorigaoka-Higashi 2-1-1-1 Asahikawa, Hokkaido, Japan
TEL	0166682583
Email	pain@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Yoshiko Middle name Last name Onodera
Organization	Asahikawa medical university
Division name	Anesthesiology & Critical Care Medicine
Zip code	0788510
Address	Midorigaoka-Higashi 2-1-1-1 Asahikawa, Hokkaido, Japan
TEL	0166682583
Homepage URL
Email	onoderayoshiko@yahoo.co.jp

Sponsor
Institute	Asahikawa medical university
Institute
Department

Funding Source
Organization	Asahikawa medical university
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	Asahikawa medical university
Address	Midorigaoka-Higashi 2-1-1-1 Asahikawa, Hokkaido, Japan
Tel	0166-68-2297
Email	sho-kenkyu@jimu.asahikawa-med.ac.jp

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	2019 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	203
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	Completed
Date of protocol fixation	2017 Year 05 Month 09 Day
Date of IRB	2017 Year 09 Month 27 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2021 Year 05 Month 11 Day
Date of closure to data entry	2021 Year 05 Month 11 Day
Date trial data considered complete	2021 Year 05 Month 11 Day
Date analysis concluded	2021 Year 05 Month 11 Day

Other
Other related information	N/A

Management information
Registered date	2019 Year 05 Month 11 Day
Last modified on	2021 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041828