UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059499 |
|---|---|
| Receipt number | R000068056 |
| Scientific Title | Internet survey on the Penetration of Constipation Guidelines Among Psychiatrists - CLIP survey |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/22 10:43:07 |
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Basic information
Public title
Internet survey on the Penetration of Constipation Guidelines Among Psychiatrists - CLIP survey
Acronym
Internet survey on the Penetration of Constipation Guidelines Among Psychiatrists - CLIP survey
Scientific Title
Internet survey on the Penetration of Constipation Guidelines Among Psychiatrists - CLIP survey
Scientific Title:Acronym
Internet survey on the Penetration of Constipation Guidelines Among Psychiatrists - CLIP survey
Region
| Japan |
Condition
Condition
constipation, schizophrenia, depression
Classification by specialty
| Gastroenterology | Psychosomatic Internal Medicine | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the current state of constipation management among psychiatric patients and the dissemination and implementation status of constipation guidelines by conducting an online survey of psychiatrists.
Basic objectives2
Others
Basic objectives -Others
Constipation is a commonly recognized gastrointestinal disorder that has been shown to impair quality of life. It has been reported that constipation occurs frequently in psychiatric disorders, including schizophrenia. Regarding constipation management, guidelines on constipation have recently been published in Japan. It is necessary to clarify the current state of constipation management among psychiatrists in Japan and the level of guideline adoption. Therefore, an online questionnaire survey was conducted among psychiatrists to clarify the current state of constipation management in psychiatric patients and the adoption and implementation status of the constipation guidelines.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Awareness and level of understanding of clinical guidelines for constipation guidelines
Key secondary outcomes
Age, gender, affiliated medical institution, membership in psychiatric specialty societies, number of patients treated and number of patients with constipation, medications used for constipation, Consideration for renal function when using magnesium oxide, consideration for concomitant medications requiring caution, status of serum magnesium level measurement, number of patients using stimulant laxatives continuously, awareness and usage status of three new mechanism-based constipation treatments, differentiation of laxative use according to constipation pathology, preferred laxative dosage form, preferred laxative administration method, aspects prioritized and their importance when prescribing laxatives, concerns regarding laxatives and their severity
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
Psychiatrists registered in the Cross Marketing Co., Ltd. research cooperation panel who have agreed to participate in this survey
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Shin |
Organization
EA Pharma Co., Ltd.
Division name
Medical Science Group, Medical Dept.
Zip code
104-0042
Address
Sumitomo Irifune Bldg, 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
090-8084-1296
tadashi_shin@epharma.co.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Shin |
Organization
EA Pharma Co., Ltd.
Division name
Medical Science Group, Medical Dept.
Zip code
104-0042
Address
Sumitomo Irifune Bldg, 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
090-8084-1296
Homepage URL
tadashi_shin@epharma.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic Research Ethics Committee
Address
1-15-9 Jiyugaoka, Meguro-ku, Tokyo
Tel
03-6777-1490
c-irb_ug@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 | 10 | Month | 27 | 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
| 2025 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068056
