UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036456 |
|---|---|
| Receipt number | 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 11:12:53 |
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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
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
yuge@nicho.co.jp
Sponsor or person
Institute
Nihon Chouzai Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041546
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| Registered date | File name |
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