UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055920 |
|---|---|
| Receipt number | R000063901 |
| Scientific Title | A 12-month single-center, single-arm comparative study on the efficacy and safety of esophageal rehabilitation for acid suppressive medication-resistant gastroesophageal reflux disease |
| Date of disclosure of the study information | 2024/10/23 |
| Last modified on | 2024/10/23 13:26:38 |
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Basic information
Public title
A 12-month single-center, single-arm comparative study on the efficacy and safety of esophageal rehabilitation for acid suppressive medication-resistant gastroesophageal reflux disease
Acronym
A 12-month study of esophageal rehabilitation for refractory gastroesophageal reflux disease
Scientific Title
A 12-month single-center, single-arm comparative study on the efficacy and safety of esophageal rehabilitation for acid suppressive medication-resistant gastroesophageal reflux disease
Scientific Title:Acronym
A 12-month single-center, single-arm comparative study of esophageal rehabilitation for acid suppressive medication-resistant gastroesophageal reflux disease
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease
Classification by specialty
| Medicine in general | Gastroenterology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Alleviation of the symptom of gastro-esophageal reflux disease (GERD)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The numerical value change of FSSG (Frequency Scale for the Symptoms of GERD) after 12 months' esophageal exercise therapy.
Key secondary outcomes
Changes in FSSG 2-4 weeks, 3 months, and 2 years after starting exercise therapy. Changes in acid suppressive medication intake and endoscopic mucosal lesions 2-4 weeks, 3 months, 1 year, and 2 years after starting exercise therapy. For those who gain consent, pH monitoring (24-hour esophageal pH monitoring or 24-hour esophageal impedance/pH monitoring) and manometry findings.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Swallowing training will be conducted 10 times at 7 to 10 seconds intervals in a supine position with their lower back raised. The program is performed twice a day for 12 months.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with GERD, whose symptom is refractory to conventional therapy including proton-pump inhibitor or vonoprazan and exhibit its FSSG score beyond 7.
Participants will be registered six years after the date of approval of this study.
Informed consent is obtained from all subjects before enrollment in the study.
Key exclusion criteria
Difficulty evaluating their own condition because of dementia or mental disturbance.
Heart or respiratory failure, spinal disease or other poor general condition.
Pregnant women or women who may be pregnant.
Those who are under the control of a randomized study regarding gastroesophageal reflux disease.
Those who are deemed inappropriate by their attending physician.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Nishimura |
Organization
Nishijin Hospital
Division name
Department of Internal Medicine
Zip code
6028319
Address
1035, Mizomaecho, Kamigyoku, kyoto, Japan.
TEL
0754618800
tnishimura@nishijinhp.com
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Nishimura |
Organization
Nishijin Hospital
Division name
Department of Internal Medicine
Zip code
6028319
Address
1035, Mizomaecho, Kamigyoku, kyoto, Japan.
TEL
0754618800
Homepage URL
tnishimura@nishijinhp.com
Sponsor or person
Institute
Nishijin Hpspital
Institute
Department
Personal name
Funding Source
Organization
Self-Funding
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
Nishijin Hospital
Address
1035, Mizomaecho, Kamigyoku, kyoto, Japan.
Tel
0754618800
tnishimura@nishijinhp.com
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
| 2024 | Year | 10 | Month | 23 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2032 | Year | 10 | 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
| 2024 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063901
