UMIN-CTR Clinical Trial

Basic information
Public title	An observational study on patients' satisfaction with oral pain medications
Acronym	An observational study on patients' satisfaction with oral pain medications
Scientific Title	An observational study on patients' satisfaction with oral pain medications
Scientific Title:Acronym	An observational study on patients' satisfaction with oral pain medications
Region	Japan

Condition
Condition	Pain/neuralgia
Classification by specialty	Neurology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify patient satisfaction with oral pain medications.
Basic objectives2	Others
Basic objectives -Others	To clarify the status of single agent prescriptions for pain treatment according to patients with neuropathic pain (NeP) and non-NeP screened in this study. To gather basic information that is the premise of subsequent clinical research in the pain field.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Patient satisfaction with NEP/non-NEP treatment. 5-point scale:Dissatisfied/ Slightly Dissatisfied/Neither/Slightly Satisfied/Satisfied
Key secondary outcomes	1. Pain relief 2. Improvement of daily life movement (ADL) 3. Degree of communication between doctor and patient <Patient background> 4. medical department that received treatment, gender, age, area 5. Drugs prescribed at the survey pharmacy last time and their prescribed amounts 6. NeP screening score (neuropathic pain screening questionnaire) 7. Pain score (NRS)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Persons aged 20 and over at the time of informed consent 2) A person who has been prescribed only one study drug for 90 consecutive days or more (with or without concomitant use of a therapeutic drug other than a drug for pain indication) 3) Those who have sufficient communication skills to participate in this study 4) Those who are being treated at a Japanese medical institution 5) Person who came for the purpose of pain relief 6) Those who agreed to participate in this study
Key exclusion criteria	1) Those who have the following possibilities within the past 90 days when obtaining consent i) I was given pain treatment by injection ii) Using oral medications other than the study drug (including OTC) for the purpose of pain relief 2) Those who are pregnant or may be pregnant
Target sample size	800

Research contact person
Name of lead principal investigator	1st name satoshi Middle name Last name yuge
Organization	Nihon Chouzai Co.,Ltd.
Division name	x
Zip code	100-6737
Address	37F 1-9-1 Marunouchi Chiyoda-ku Tokyo,Japan
TEL	03-6810-0800
Email	yuge@nicho.co.jp

Public contact
Name of contact person	1st name satoshi Middle name Last name yuge
Organization	Nihon Chouzai Co.,Ltd.
Division name	x
Zip code	100-6737
Address	37F 1-9-1 Marunouchi Chiyoda-ku Tokyo,Japan
TEL	03-6810-0800
Homepage URL
Email	yuge@nicho.co.jp

Sponsor
Institute	Nihon Chouzai Co.,Ltd.
Institute
Department

Funding Source
Organization	Daiichi-Sankyo Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Site Support Institute Co.,Ltd.
Address	17F 1-1-1 Shibaura Minato-ku Tokyo,Japan
Tel	070-5011-8550
Email	shingo-namiki@j-smo.com

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	日本調剤関連薬局

Other administrative information
Date of disclosure of the study information	2019 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	781
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	2019 Year 03 Month 19 Day
Date of IRB	2019 Year 03 Month 19 Day
Anticipated trial start date	2019 Year 04 Month 15 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2019 Year 08 Month 19 Day
Date trial data considered complete	2019 Year 08 Month 19 Day
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information	x

Management information
Registered date	2019 Year 04 Month 09 Day
Last modified on	2019 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041546