UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042851 |
|---|---|
| Receipt number | 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 15:04:01 |
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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
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
sayo.hashimoto@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
NA
Address
NA
Tel
NA
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048916
