UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021568
Receipt number R000024868
Scientific Title Exploratory research on latent esophageal motility disorders in non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs)
Date of disclosure of the study information 2016/04/01
Last modified on 2016/03/22 17:59:08

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Basic information

Public title

Exploratory research on latent esophageal motility disorders in non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs)

Acronym

esophageal motility disorders in NERD

Scientific Title

Exploratory research on latent esophageal motility disorders in non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs)

Scientific Title:Acronym

esophageal motility disorders in NERD

Region

Japan


Condition

Condition

non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate latent esophageal motility disorders associated with PPI-resistant NERD.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The study was carried with patients who had been diagnosed as having PPI-resistant NERD, showed no erosive esophageal mucosal damage, and showed no alleviation of dysphagia symptoms after administration of standard doses of PPIs for at least 8 weeks. After enrolment, the presence or absence of esophageal motility disorder was evaluated on the basis of the Chicago classification, using HRM.

Key secondary outcomes

Efficacy of the PPI for NERD


Base

Study type

Others,meta-analysis etc


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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

(i) Principal complaint: dysphagia.
(ii) Organic disease ruled out by upper gastrointestinal endoscopy.
(iii) Experienced no alleviation of symptoms despite use of the standard PPI dose for at least 8 weeks.

Key exclusion criteria

(i) Drug administration and/or endoscope insertion made difficult by constriction or deformation of the upper gastrointestinal tract.
(ii) Suffering from active malignant tumors, or other serious, systemic complications.
(iii) Suffering from active ulcers.
(iv) Suffering from serious complications, such as heart, kidney, liver, or respiratory failure.
(v) A history of treatment of the upper abdomen with radiotherapy.
(vi) A history of surgical treatment of the gastrointestinal tract.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihisa Takeuchi

Organization

Osaka Medical Collage

Division name

Depertment of 2nd. internal medicine

Zip code


Address

2-7, Daigakumachi, Takatsuki-shi, Osaka, Japan

TEL

0726831221

Email

in2097@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshihisa Takeuchi

Organization

Osaka Medical Collage

Division name

Depertment of 2nd. internal medicine

Zip code


Address

2-7, Daigakumachi, Takatsuki-shi, Osaka, Japan

TEL

0726831221

Homepage URL


Email

in2097@poh.osaka-med.ac.jp


Sponsor or person

Institute

Depertment of 2nd. internal medicine, Osaka Medical Collage

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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 04 Month 01 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

The subjects of the study were 100 patients who suffered from dysphagia; were examined and treated at Hospital between July 2011 and December 2013; had organic disease ruled out by upper gastrointestinal endoscopy; showed no alleviation of symptoms despite administration of the standard dose of a PPI for at least 8 weeks; were at least 20 years old; and were diagnosed as having PPI-resistant NERD. The mean age was 59.31years, and 45 males and 55 females were included, with mean ages of 58.80 and 59.73 years, respectively.

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

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2014 Year 03 Month 01 Day


Other

Other related information

The breakdown of the 100 subjects was by classification of disease types in accordance with the flowchart in the 2012 Chicago classification criteria.
Firstly, 29 subjects were found to have IRP values, used to evaluate the residual pressure at relaxation of the lower esophageal sphincter, of 15 mmHg or higher. Of these patients, 13 had achalasia, with no normal primary peristaltic waves (Fig. 2); and 16 had EGJ outflow obstruction, with normal primary peristaltic waves (Fig. 3). Next, the group of subjects with IRPs below 15 mmHg consisted of three subjects with diffuse esophageal spasms, with distal latency periods of less than 4.5 s; and seven subjects with hypertensive peristalsis, defined as a distal contractile integral, used to evaluate the strength of peristaltic wave contraction, of at least 5000 mmHg/s/cm (Fig. 4). In addition to the above subjects, 14 subjects had weak peristalsis, with breaks of 2 cm or more in the 20-mmHg isobar (Fig. 5); and five had frequent failed peristalsis, with at least three peristaltic failures in 10 swallowing events. Furthermore, 40 subjects with whom all the above conditions were ruled out were judged to be normal. Finally, there were two subjects with whom insertion was not possible, of whom one was diagnosed as having achalasia on the basis of barium swallowing (Fig. 6), whereas with the other barium swallowing resulted in the barium remaining in the pharynx, indicating the impatency of the pharynx, so the condition was re-diagnosed as oropharyngeal dysphagia.


Management information

Registered date

2016 Year 03 Month 22 Day

Last modified on

2016 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024868


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name