UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028245 |
|---|---|
| Receipt number | R000032324 |
| Scientific Title | Effects on abdominal symptoms of guanylate cyclase C-receptor agonist |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2018/10/11 14:49:52 |
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Basic information
Public title
Effects on abdominal symptoms of guanylate cyclase C-receptor agonist
Acronym
Effects on abdominal symptoms of Linaclotide
Scientific Title
Effects on abdominal symptoms of guanylate cyclase C-receptor agonist
Scientific Title:Acronym
Effects on abdominal symptoms of Linaclotide
Region
| Japan |
Condition
Condition
Irritable bowel syndrome
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect on abdominal symptoms other than constipation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in subjective symptoms 2 weeks after satrting administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of Linaclotide for 2 weeks
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients adepted for Linaclotide
Key exclusion criteria
1. Patients who were diagnosed or suspected mechanical gastrointestinal obstruction
2. Patients with history of hypersensitivity to Linaclotide
3. Pregnant women or lactating women or patients who may have pregnancy
4. Cases judged inappropriate by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabe Noriaki |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
Address
577 Matsushima, Kurashiki
TEL
086-462-1111
cda40950@hkg.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabe Noriaki |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
Address
577 Matsushima, Kurashiki
TEL
086-462-1111
Homepage URL
cda40950@hkg.odn.ne.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Address
Tel
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
| 2017 | Year | 07 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032324
