Prevalence of Gastroesophageal Reflux Disease in Peritone... | NCT01634672

Studies
Prevalence of Gastroesophageal Reflux Disease in Peritoneal Dialysis and Hemodialysis Patients

NCT01634672

Sponsor

Song Kyung Ho

Status

Unknown status

Last Update Posted

Jul 6, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Oct 2012Estimated

First Submitted Date

Jul 3, 2012

First Submission Date that Met QC Criteria

Jul 5, 2012

First Posted Date

Jul 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2012

Last Update Posted Date

Jul 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.

Detailed Description

Gastroesophageal reflux disease is a common upper gastrointestinal disorder in chronic kidney disease. But, little is known about the prevalence in dialysis patients. The aims of this study were to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis		2 yrs

Secondary Outcomes

Measure	Description	Time Frame
risk factor for GERD in peritoneal dialysis and hemodialysis patients		2 yrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

peritoneal dialysis and hemodialysis patients

Exclusion Criteria:

a history of abdominal surgery or with a proton pump inhibitor before 1 month and a eradication of H. pylori were excluded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with chronic kidney disease undergoing peritoneal dialysis and hemodialysis over 1 year were enrolled

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyun jung Song, Bechelor's	Konyang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konyang Univ.Hospital		Daejeon		302-718	South Korea

Type	Date	Date Unknown
Release	Aug 20, 2012
Reset	Sep 20, 2012
Release	Oct 1, 2012
Reset	Oct 30, 2012

Submission Tracking

Estimated Results First Submitted Date

Aug 20, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 20, 2012			Sep 20, 2012
Oct 1, 2012

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided