UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007337 |
|---|---|
| Receipt number | R000008645 |
| Scientific Title | The efficacy of oral conbination administration of tranilast and steroid for the prevention of esophageal stricture after ESD |
| Date of disclosure of the study information | 2012/02/20 |
| Last modified on | 2018/02/27 15:33:57 |
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Basic information
Public title
The efficacy of oral conbination administration of tranilast and steroid for the prevention of esophageal stricture after ESD
Acronym
The randomised controlled trial of oral administration of tranilast and steroid for preventing esophageal stricture after ESD
Scientific Title
The efficacy of oral conbination administration of tranilast and steroid for the prevention of esophageal stricture after ESD
Scientific Title:Acronym
The randomised controlled trial of oral administration of tranilast and steroid for preventing esophageal stricture after ESD
Region
| Japan |
Condition
Condition
subcircunferentialand circumferential esophageal sqamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the preventitive effect of oral administration of steroid and tranilast for esophageal stricture after ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of esophageal stricture after circumferential or subsircunferential ESD
Key secondary outcomes
The number of endoscopic balloon dilation for treating esophageal stricture, The symptomatic scoring of dysphagia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
combinative administration of tranilast and steroid for 6 weeks after ESD
Interventions/Control_2
combinative administration of placebo and steroid for 6 weeks after ESD
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients suffering from superficial esophageal sqaumoua cell carcinoma whose circumference are more than 3/4 by endoscopic examination with lugor spray
Key exclusion criteria
patients with contraindication of medication, having severe complication, having had previous treatment of CRT/RT or operation for cervical or thracic or upper abdominal diseases, having medication which might affect the effect of tranilast or steroid
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaname Uno |
Organization
Tohoku University
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsunori Iijima |
Organization
Tohoku University
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi Japan
TEL
Homepage URL
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 20 | 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
| 2010 | Year | 05 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008645
