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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043985
Receipt No. R000050188
Scientific Title A survey of constipation in chronic non-cancer pain patients using opioid analgesics
Date of disclosure of the study information 2021/04/28
Last modified on 2021/04/20

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Basic information
Public title A survey of constipation in chronic non-cancer pain patients using opioid analgesics
Acronym A survey of constipation in chronic non-cancer pain patients
Scientific Title A survey of constipation in chronic non-cancer pain patients using opioid analgesics
Scientific Title:Acronym A survey of constipation in chronic non-cancer pain patients
Region
Japan

Condition
Condition Constipation
Classification by specialty
Gastroenterology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the character of opioid induced constipation based on ROMA-IV diagnostic criteria in chronic non-cancer pain patients by comparison between the patients using opioid analgesics and non-opioid analgesics
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes aware of constipation
bowel pattern
constipation strategy
constipation using ROME-IV Criteria
bowel pattern using ROME-IV Criteria
PAC-QOL
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Men or women living in Japan aged 20 and over
2. Subjects who use opioid analgesics (strong/weak) or other Analgesics for 3 months or more
3. Subjects who give approval and answer questionnaires in the Web site
Key exclusion criteria cancer patients
Target sample size 1000

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, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL 06-6202-2161
Email shinzo.hiroi@shionogi.co.jp

Public contact
Name of contact person
1st name Hirokazu
Middle name
Last name Mishima
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 06-6202-2161
Homepage URL
Email hirokazu.mishima@shionogi.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

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
Email 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
2021 Year 04 Month 28 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
2021 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2021 Year 04 Month 20 Day
Last modified on
2021 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050188

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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