UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021190 |
|---|---|
| Receipt number | R000024436 |
| Scientific Title | Safety and efficacy of botulinum toxin injection therapy on patients with esophageal motility disorders |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2019/09/04 21:45:52 |
* 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
Safety and efficacy of botulinum toxin injection therapy on patients with esophageal motility disorders
Acronym
botulinum toxin injection therapy for esophageal motility disorders
Scientific Title
Safety and efficacy of botulinum toxin injection therapy on patients with esophageal motility disorders
Scientific Title:Acronym
botulinum toxin injection therapy for esophageal motility disorders
Region
| Japan |
Condition
Condition
Esophageal motility disorders except for achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of botulinum toxin injection therapy on patients with esophageal motility abnormalities except for achalasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of symptoms
Key secondary outcomes
Safety of botulinum toxin injection therapy
duration of botulinum toxin injection therapy's effect
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
Botulinum toxin injection therapy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with esophageal motility abnormalities except for achalasia
Key exclusion criteria
1. Patients with neuromuscular disorders
2. Patients who have esophageal varices
3. Patients whose esophagus is excluded by other organs
4. Patients with severe respiratory dysfunction
5. Pregnant patients or patients nursing a child
6. Patients who have allergy for botulinum toxin
7. Patients who are considered as an inappropriate subject for the study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Motoyasu |
| Middle name | |
| Last name | Kusano |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8137
mkusano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8137
Homepage URL
shikokuri@yahoo.co.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
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
Gunma University Hospital
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8137
shikokuri@gunma-u.ac.jp
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
| 2016 | Year | 02 | 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
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
| 2015 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024436
