Trial record 6 of 13 for:    hong proton | Open Studies | Exclude Unknown

Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI in Chinese Population: PASS-C

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02437682
First received: May 5, 2015
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

The PASS test is only available and valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. There is lack of a validated Chines version of PASS questionnaire for the GERD patients with partial response to proton pump inhibitor (PPI). The English version of PASS test will be translated to traditional Chinese by using forward-backward procedure, and the Chinese version of PASS test will be validated its psychometric properties in Hong Kong population.

Eligible subjects will be invited to administer questionnaires to evaluate the psychometric properties of the Chinese version of PASS test.


Condition
Gastro-esophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Translation and Validation of the PASS Test for Gastro-esophageal Reflux Disease (GERD) Patients With Partial Response to PPI in Chinese Population: PASS-C

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • PASS_C questionnaire [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Gastro-esophageal reflux disease (GERD) is a common condition defined as symptoms or mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. Symptoms highly specific for GERD are heartburn, regurgitation, or both, which often occur after meals. The prevalence of GERD is around 20% for weekly reflux symptoms in the Western population, while 9.3% in Chinese population. However, approximately 20-30% of patients with GERD experience only a partial response of their heartburn of regurgitation symptoms to PPI therapy.

There is lack of a validated Chines version of PASS questionnaire for the GERD patients with partial response to PPI.

Before a treatment response assessment tool can be used clinically, various questions on reliability and validity of the instrument need to be addressed. The aims of this study are (1) to translate the PASS test from English to traditional Chinese, named PASS-C, and (2) to assess the psychometric properties of the PASS-C, before clinical application.

Linguistic translation of the PASS questionnaire from English to Chinese version will follow a forward-backward procedure.

After finalization of Chinese version of the PASS (PASS-C), the reliability of PASS-C will be evaluated for internal consistency using Cronbach's alpha. The intraclass correlation coefficient was calculated within 14 days for two surveys in order to evaluate the reproducibility of the results under constant conditions. Pearson product moment correlation coefficient will be used to evaluate whether PASS-C can measure what it claims to measure by comparing with SF-12v2, GERD QOL and GREDSQ scores.

All eligible subjects will be invited to complete PASS-C twice within 14 days under a stable condition. In addition to PASS-C, all patients will have to complete SF-12v2, GERD-QOL, GERDQ and GERDSQ questionnaires.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject has been taking any PPI and still has persistent GERD symptoms during PPI therapy

Criteria

Inclusion Criteria:

  • Able to give study informed consent
  • Male or female. Age 18 or above
  • Have at least 6 months history of GERD symptoms (need not to be consecutive) as chief complaint, e.g. acid regurgitation or heartburn
  • Subject has been taking any PPI at standard dose for at least 8 weeks Subject has persistent symptoms during PPI therapy with GERDQ score ≥8
  • An upper gastrointestinal endoscopy is required within the past 1 year to confirm the absence of mucosal breaks, peptic ulcer and other GI diseases e.g. gastric outlet obstruction

Exclusion Criteria:

  • Patients that have not experienced any GERD symptom improvement at all during PPI treatment
  • Unstable or clinically significant cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric, other clinical disorders, or gastrointestinal and esophageal disorders besides GERD. Clinically significant is defined as disorders that could compromise patients' safety or interfere with the evaluation of the study as judged by the investigator.
  • History of or current malignant disease
  • Subject is pregnant or lactating
  • Prior surgery of the upper GI tract (open, endoscopic and laparoscopic surgery on the esophagus, the stomach and the duodenum)
  • Illiterate patient (who cannot administer questionnaire)
  • Known hypersensitivity to any PPI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02437682

Contacts
Contact: Justin C.Y. Wu, MBChB(CUHK) (852)2632 3855 justinwu@cuhk.edu.hk
Contact: Pui Kuan Cheong, MSc (852)2632 3855 jcheong@cuhk.edu.hk

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Justin C.Y. Wu, MBChB(CUHK) Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02437682     History of Changes
Other Study ID Numbers: PASS-C
Study First Received: May 5, 2015
Last Updated: May 6, 2015
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Gastro-esophageal Reflux Disease
Proton pump inhibitor

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 27, 2015