UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052629 |
|---|---|
| Receipt number | R000059886 |
| Scientific Title | Exploratory Study on Medication Understanding and Treatment Satisfaction in Patients Taking New Oral Pain Medications |
| Date of disclosure of the study information | 2023/10/27 |
| Last modified on | 2025/04/25 17:46:08 |
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Basic information
Public title
Exploratory Study on Medication Understanding and Treatment Satisfaction in Patients Taking New Oral Pain Medications
Acronym
Exploratory Study on Medication Understanding and Treatment Satisfaction in Patients Taking New Oral Pain Medications
Scientific Title
Exploratory Study on Medication Understanding and Treatment Satisfaction in Patients Taking New Oral Pain Medications
Scientific Title:Acronym
Exploratory Study on Medication Understanding and Treatment Satisfaction in Patients Taking New Oral Pain Medications
Region
| Japan |
Condition
Condition
Pain
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct an exploratory analysis of the relationship between medication understanding and treatment satisfaction among patients taking new oral pain medications.
To further explore and identify factors influencing treatment satisfaction.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment satisfaction
Key secondary outcomes
Medication understanding
Information about medication explanation (This includes explanation content, who provided the explanation, and the medium of the explanation)
Information about medication discontinuation (This includes whether the medication was discontinued, reasons for discontinuation, and treatments following discontinuation)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with a history of taking new oral pain medications since April 2023.
2)Patients aged 18 and over at the time of consent.
3)Patients capable of giving consent via electronic methods (Web) based on their own free will for participation in the study.
4)Patients who can appropriately respond to questions in Japanese via electronic methods (Web) without assistance.
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kimura |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo
TEL
03-6225-1053
kimura.tetsuya.d2@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | Seki |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai Chiyoda-ku, Tokyo
TEL
03-5295-1579
Homepage URL
haruhiko.seki@intage.com
Sponsor or person
Institute
DAIICHI SANKYO 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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000059886
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s40122-025-00709-7
Number of participants that the trial has enrolled
328
Results
The percentage of patients who were highly satisfied with their oral pain reliever (primary endpoint) was 71.6%.
Results date posted
| 2025 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 08 | Day |
Baseline Characteristics
The mean age of the patients enrolled was 53.4 years, 66.2% of patients were female.
Patients prescribed lasmiditan tended to be younger (mean age, 42.7 years) and the proportion of women was higher (79.3%) compared with patients prescribed mirogabalin (59.8 years, 58.9% female) or tramadol (58.6 years, 55.6% female).
The proportion of patients who had used oral pain relievers for one month or longer was higher for the mirogabalin recipients (75.6%) compared with lasmiditan (59.5%) and tramadol (55.6%) recipients.
Participant flow
Of the 354 patients who provided electronic informed consent, 328 met the eligibility criteria.
Adverse events
Not collected
Outcome measures
The overall percentage of patients with high understanding was 68.0% (n = 223/328).
The percentage of the satisfied group for overall treatment satisfaction were 83.4% (186/223) in the high understanding group, 47.6% (39/82) in the moderate understanding group, and 43.5% (10/23) in the low understanding group, indicating that the higher the level of treatment satisfaction, the higher the drug understanding.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To conduct an exploratory analysis of the relationship between medication understanding and treatment satisfaction among patients taking new oral pain medications.
To further explore and identify factors influencing treatment satisfaction.
Management information
Registered date
| 2023 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059886
