UMIN-CTR Clinical Trial

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
Email	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
Email	shikokuri@yahoo.co.jp

Sponsor
Institute	Gunma University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024436