UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050413 |
|---|---|
| Receipt number | R000057401 |
| Scientific Title | A questionnaire survey on QOL in chronic non-cancer pain patients with opioid-induced constipation |
| Date of disclosure of the study information | 2023/02/22 |
| Last modified on | 2023/02/22 15:20:01 |
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Basic information
Public title
A questionnaire survey on QOL in chronic non-cancer pain patients with opioid-induced constipation
Acronym
A questionnaire survey on QOL in chronic non-cancer pain patients with opioid-induced constipation
Scientific Title
A questionnaire survey on QOL in chronic non-cancer pain patients with opioid-induced constipation
Scientific Title:Acronym
A questionnaire survey on QOL in chronic non-cancer pain patients with opioid-induced constipation
Region
| Japan |
Condition
Condition
Opioid Induced Constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the QOL, pain condition, labor productivity, satisfaction with analgesics, and adherence to analgesics in chronic non-cancer pain patients using weak opioid analgesics with opioid induced constipation (OIC) in Japan.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-36 score (v2, acute)
Key secondary outcomes
SF-36 summary score (v2, acute)
Numerical Pain Scale (NRS)
SF-MPQ-2
WPAI:GH
Satisfaction with analgesics
Adherence to analgesics
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 18 years of age or older living in Japan
2) Patients with a history of treated with analgesics over 3 months
3) Patients with a history of treated with weak opioids over 1 month
4) Patients who have given their consent to participate in this study
Key exclusion criteria
1) Patients with cancer
2) Patients with a history of treated with strong opioids
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Shinzo |
| Middle name | |
| Last name | Hiroi |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
541-0045
Address
1-8, Dosho-machi 3-chome, Chuo-ku, Osaka
TEL
080-2425-7440
shinzo.hiroi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yasuhide |
| Middle name | |
| Last name | Morioka |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
541-0045
Address
1-8, Dosho-machi 3-chome, Chuo-ku, Osaka
TEL
070-7812-6306
Homepage URL
yasuhide.morioka@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & 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
Yoyogi Mental Clinic Research Ethics Committee
Address
3F,4-26-11 Sendagaya,Shibuya-ku,Tokyo 151-0051 Japan
Tel
03-5413-6662
cns_jimu@triad-j.co.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
| 2023 | Year | 02 | Month | 22 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
questionnaire survey(cross-sectional study)
Management information
Registered date
| 2023 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057401
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
