UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059932 |
|---|---|
| Receipt number | R000068188 |
| Scientific Title | An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/01 15:54:35 |
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Basic information
Public title
An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients
Acronym
An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients
Scientific Title
An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients
Scientific Title:Acronym
An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients
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 exploratorily investigate the prescription patterns of therapeutic agents for gastrointestinal adverse events in patients initiated weak opioid analgesics.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Patient Background
2. Proportion of patients who had addition, dose escalation, or change in constipation medication
3. Proportion of patients who had addition of constipation medication
4. Proportion of patients who had dose escalation of constipation medication
5. Proportion of patients who had change in constipation medication
6. Proportion of patients who had dose reduction or discontinuation of constipation medication
7. Duration from initiation of weak opioid analgesics to achieving optimal regimen of prescribed constipation medication
8. Proportion of patients who were prescribed antiemetic medication
9. Prescribed quantity of weak opioid analgesics (mean, median)
10.Change in quantity of weak opioid analgesics from the start of prescription until the end of the observation Period
11.Types and details of constipation medications added or changed
12.Period Between Initiation of Weak Opioid Analgesics and Addition or Change of Prescribed Constipation Medication
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who were prescribed weak opioid analgesics (tramadol hydrochloride, tramadol-acetaminophen combination, codeine, Buprenorphine) for non-cancer pain from April 2017 to March 2024.
2.Patients who had a visit after week 13 following the initial prescription of weak opioid analgesics Patients with all of the following data
-Patient demographics (age, gender, underlying condition causing pain)
-Prescription information of weak opioid analgesics (prescription date, drug name, prescribed dosage (/day))
Key exclusion criteria
1.Patients who have declined participation in this study (opt-out method)
2.Patients with opioid analgesics up to 4 weeks before starting weak opioid analgesics
3.Patients who have a diagnosis of cancer (excluding carcinoma in situ) at the time of starting weak opioid analgesics
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Misato |
| Middle name | |
| Last name | Kitamura |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
070-7812-7077
misato.kitamura@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Shihomi |
| Middle name | |
| Last name | Wada |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
080-2525-9360
Homepage URL
shihomi.wada@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
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F , 5-1-31 ,kitamachi ,iwaya, 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
| 2025 | Year | 12 | Month | 05 | 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
2000
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An exploratory cohort study using single-center electronic medical record
Management information
Registered date
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068188
