NCT00963144

Brief Summary

The purpose of the study is to determine the applicability and utility of Gerd Q in the diagnosis of GERD and in the assessment of treatment response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

4 months

First QC Date

August 12, 2009

Last Update Submit

October 20, 2010

Conditions

Gastroesophageal Reflux Disease

Keywords

Gerd Questionnaire

Outcome Measures

Primary Outcomes (1)

  • To determine the applicability and utility of Gerd Q in the diagnosis of GERD and assessment of treatment response

    The applicability and utility of the Gerd Questionnaire will be done on 2 vists- Day 1 and Day 30

Secondary Outcomes (1)

  • To assess and monitor the treatment response of patients diagnosed with GERD

    The monitoring and assessment of treatment response using the Gerd Questionnaire will be done on 2 vists-Day 1 and Day 30

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Patients of either gender aged between 18-79 years of age
  • Patients must be having symptoms of gastroesophageal reflux disease

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Kuala Lumpur, Malaysia

Location

Research Site

Kuala Selangor, Malaysia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Goh Khean Lee, MBBS, MRCP, FRCP

    Faculty of Medicine, University of Malaya Medical Center (UMMC),

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 21, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

October 21, 2010

Record last verified: 2010-10

Locations

MY(2)