UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050203 |
|---|---|
| Receipt number | R000056854 |
| Scientific Title | Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2024/02/15 15:41:44 |
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Basic information
Public title
Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan
Acronym
Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan
Scientific Title
Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan
Scientific Title:Acronym
Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan
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 incidence of opioid-induced constipation (OIC) and the effects of OIC on quality of life in patients with chronic non-cancer musculoskeletal pain using weak opioid analgesics in routine clinical practice in Japan
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of OIC in 2 weeks after starting weak opioid analgesics (ROME-IV diagnostic criteria)
Key secondary outcomes
The following outcomes in 2 weeks after starting weak opioid analgesics
- Incidence of OIC (per day, per week)
- Incidence of symptoms of OIC
- Proportion of patients who consider themselves to be constipated
- PAC-SYM score
- SF-36 v2 acute score
- NRS score
- Proportion of patients who take laxatives
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 with chronic musculoskeletal pain
2) Patients newly prescribed weak opioid analgesics and plan to take them for over 2 weeks
3) Patients before or within 1 day of starting weak opioid analgesics
4) Patients with more than 3 spontaneous bowel movements in a week before
5) Patients who can download the application and answer the web questionnaire by using mobile devices (smart phone, tablet etc.)
6) Patients who have given their consent to participate in this study
Key exclusion criteria
1) Patients with a history of treated with opioids within the past 4 weeks
2) Hospitalized patients
3) Patients with malignant tumors
4) Patients with two or more of the following constipation symptoms in the past week prior to starting weak opioid analgesics
a. Straining during more than 1/4 (25%) of defecations
b. Lumpy or hard stools (Bristol Stool Form Scale 1-2) during more than 1/4 (25%) of defecations
c. Sensation of incomplete evacuation during more than 1/4 (25%) of defecations
d. Sensation of anorectal obstruction/blockage during more than 1/4 (25%) of defecations
e. Manual maneuvers to facilitate more than 1/4 (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
f. Fewer than three SBM (spontaneous bowel movement) per week
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuhide |
| Middle name | |
| Last name | Morioka |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
541-0045
Address
1-8, Dosho-machi 3-chome, Chuo-ku, Osaka
TEL
070-7812-6306
yasuhide.morioka@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 Department
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Takahashi Clinic
Address
5-1-31 Iwayakita-machi, Nada-ku, Kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.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 | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will collect information by questionnaires to patients.
The information collected is the information shown in the endpoints.
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056854
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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