UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041142
Receipt number R000046428
Scientific Title Prevalence of Behavioral Disorders in Patients with Vonoprazan-refractory Reflux Symptoms.
Date of disclosure of the study information 2020/07/17
Last modified on 2022/07/19 11:41:17

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Basic information

Public title

Behavioral disorders in patients with reflux symptoms which are resistant to vonoprazan

Acronym

Behavioral disorders in patients with reflux symptoms

Scientific Title

Prevalence of Behavioral Disorders in Patients with Vonoprazan-refractory Reflux Symptoms.

Scientific Title:Acronym

Behavioral Disorders in GERD

Region

Japan


Condition

Condition

Gastroesophageal reflux disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the proportion of patients with supragastric belching and rumiantion syndrome in vonoprazan-refractory patients in Japan

Basic objectives2

Others

Basic objectives -Others

Prevalence

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the proportion of patients with supragastric belching and rumiantion syndrome in vonoprazan-refractory patients

Key secondary outcomes

To investigate predictive factors of behavioral disorders.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with VPZ-refractory reflux symptoms who were referred to our tertiary referral center in Tokyo, Japan between January 2015 and March 2020. The eligibility criteria were (i) 18 years or older; (ii) persistent reflux symptoms (heartburn or regurgitation) despite a 2-week treatment with 20 mg VPZ; (iii) never been diagnosed with reflux esophagitis; and (iv) adequate records of HRM, MIIpH on 20 mg VPZ, and EGD, which were performed within 6 months.

Key exclusion criteria

(i) patients diagnosed with endoscopic esophagitis
(ii) patients who had impedance-pH metry off vonoprazan 20mg

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshimasa
Middle name
Last name Hoshikawa

Organization

Nippon Medical School

Division name

Department of Gastroenterology

Zip code

113-8603

Address

1-1-5 Sendagi Bunkyo-ku Tokyo, Japan

TEL

03-3822-2131

Email

y-hoshikawa@nms.ac.jp


Public contact

Name of contact person

1st name Yoshimasa
Middle name
Last name Hoshikawa

Organization

Nippon Medical School

Division name

Department of Gastroenterology

Zip code

113-8603

Address

1-1-5 Sendagi Bunkyo-ku Tokyo, Japan

TEL

03-3822-2131

Homepage URL


Email

y-hoshikawa@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School

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

Nippon Medical School Ethics Comittee

Address

1-1-5 Sendagi Bunkyo-ku Tokyo, Japan

Tel

03-3822-2131

Email

clinicaltrial@nms.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

2020 Year 07 Month 17 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/33247348/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33247348/

Number of participants that the trial has enrolled

49

Results

Among 49 patients, 6 (12.2%) had SGB, 4 (8.2%) possible RS, 29 (59.2%) FH, 9 (18.4%) RH, and 1 (2%) NERD. Possible RS patients had more postprandial non-acid reflux events than FH patients (p < 0.05). The multivariate logistic regression analysis did not identify any predictive factors with statistical significance.

Results date posted

2022 Year 07 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We retrospectively analyzed high-resolution manometry (HRM), 24-h multiluminal impedance pH-metry (MIIpH), and esophagogastroduodenograms (EGD) in patients with VPZ-refractory reflux symptoms who were referred to our tertiary referral center in Tokyo, Japan between January 2015 and April 2020. Eligibility criteria were (i) 18 years or older; (ii) persistent reflux symptoms (heartburn or regurgitation) despite a 2-week treatment with 20 mg VPZ; (iii) never been diagnosed with reflux esophagitis; and (iv) adequate records of HRM, MIIpH on 20 mg VPZ, and EGD, which were performed within 6 months. This protocol was approved by the Ethics Committee for Human Research of Nippon Medical School [B-2020-152]. The present study was registered in the UMIN clinical trial register system [UMIN000041142].

Participant flow

We retrospectively analyzed high-resolution manometry (HRM), 24-h multiluminal impedance pH-metry (MIIpH), and esophagogastroduodenograms (EGD) in patients with VPZ-refractory reflux symptoms who were referred to our tertiary referral center in Tokyo, Japan between January 2015 and April 2020. Eligibility criteria were (i) 18 years or older; (ii) persistent reflux symptoms (heartburn or regurgitation) despite a 2-week treatment with 20 mg VPZ; (iii) never been diagnosed with reflux esophagitis; and (iv) adequate records of HRM, MIIpH on 20 mg VPZ, and EGD, which were performed within 6 months. This protocol was approved by the Ethics Committee for Human Research of Nippon Medical School [B-2020-152]. The present study was registered in the UMIN clinical trial register system [UMIN000041142].

Adverse events

none

Outcome measures

The primary outcome was the proportion of patients with behavioral disorders (SGB and possible RS). The secondary outcome was predictive factors for behavioral disorders.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 05 Month 01 Day

Date of IRB

2020 Year 07 Month 17 Day

Anticipated trial start date

2020 Year 07 Month 17 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We retrospectively analyzed High Resolution Manometry (HRM), 24hour Multichannel Impedance pH-metry (MIIpH), and Esophagogastroduodenogram (EGD) in patients with VPZ-refractory reflux symptoms. We divided patients into 4 groups: Functional Heartburn, Reflux Hypersensitivity, Dupragastric Belching, Rumination Syndrome. We calculated the proportion of each group and investigated predictive factors if rumination syndrome and supragastric belching


Management information

Registered date

2020 Year 07 Month 17 Day

Last modified on

2022 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046428


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name