UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021568
Receipt No. 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

* 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 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
Institute Depertment of 2nd. internal medicine, Osaka Medical Collage
Institute
Department

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
URL(English) https://upload.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


Contact us.