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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036456
Receipt No. R000041546
Scientific Title An observational study on patients' satisfaction with oral pain medications
Date of disclosure of the study information 2019/04/15
Last modified on 2019/10/09

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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

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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