UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002741 |
|---|---|
| Receipt number | R000003333 |
| Scientific Title | Evaluation of preventive effect of tranilast on esophageal stricture after extensive endoscopic submucosal dissection (ESD) therapy for superficial esophageal cancer. |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2012/06/22 16:05:49 |
* 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
Evaluation of preventive effect of tranilast on esophageal stricture after extensive endoscopic submucosal dissection (ESD) therapy for superficial esophageal cancer.
Acronym
Preventive effect of tranilast on esophageal stricture after ESD
Scientific Title
Evaluation of preventive effect of tranilast on esophageal stricture after extensive endoscopic submucosal dissection (ESD) therapy for superficial esophageal cancer.
Scientific Title:Acronym
Preventive effect of tranilast on esophageal stricture after ESD
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Esophageal stricture inevitably occurs after extensive ESD. The aim of this study is to evaluate preventive effect of tranilast on the post-trreatment esophageal stricture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The numbers of balloon esophageal dilation required for the post-treatment stricture & patients' symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tranilast
Interventions/Control_2
placebo
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
Patients who undergo extensive ESD (more than 2/3 circumference) for superficial esophageal cancer.
Key exclusion criteria
Patients who requires additional treatments such as radiation or operation due to deep invasion of esophageal cancer.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uno Kaname |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
Sendai, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | iijima Katsunori |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
TEL
Homepage URL
jiijima@int3.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 10 | Day |
Last modified on
| 2012 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003333
