UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042851
Receipt No. R000048916
Scientific Title Drug Use-Results Survey for SYMPROIC Tablets 0.2mg in cancer patients with opioid-induced constipation
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Drug Use-Results Survey for SYMPROIC Tablets 0.2mg in cancer patients with opioid-induced constipation
Acronym Drug Use-Results Survey for SYMPROIC Tablets 0.2mg in cancer patients with opioid-induced constipation
Scientific Title Drug Use-Results Survey for SYMPROIC Tablets 0.2mg in cancer patients with opioid-induced constipation
Scientific Title:Acronym Drug Use-Results Survey for SYMPROIC Tablets 0.2mg in cancer patients with opioid-induced constipation
Region
Japan

Condition
Condition Opioid-induced constipation
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and the efficacy of SYMPROIC Tablets 0.2mg in cancer patients with opioid-induced constipation under actual use conditions
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Incidence rates of adverse drug reactions
Key secondary outcomes Improvement rates of frequency and condition of bowel movement (2 weeks later, 4 weeks later, 8 weeks later,12 weeks later or at discontinuation)

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 Cancer patients with opioid-induced constipation who administrate SYMPROIC Tablets for the first time
Key exclusion criteria NA
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Sawada
Organization Shionogi & Co., Ltd.
Division name Pharmacovigilance Department
Zip code 541-0045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-6974
Email masaru.sawada@shionogi.co.jp

Public contact
Name of contact person
1st name Sayo
Middle name
Last name Hashimoto
Organization Shionogi & Co., Ltd.
Division name Pharmacovigilance Department
Zip code 541-0045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-6990
Homepage URL
Email sayo.hashimoto@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 NA
Address NA
Tel NA
Email NA

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
2020 Year 12 Month 25 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 1202
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 Completed
Date of protocol fixation
2017 Year 06 Month 16 Day
Date of IRB
2017 Year 06 Month 16 Day
Anticipated trial start date
2018 Year 01 Month 22 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Approval by IRB is not necessary.

Management information
Registered date
2020 Year 12 Month 25 Day
Last modified on
2020 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.