Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With GERD (RANGE)

March 10, 2009 updated by: AstraZeneca

A Cross-Sectional, Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With Gastroesophageal Reflux Disease (GERD) RANGE: Retrospective ANalysis of GErd

This is a cross-sectional study of symptom burden and clinical management. A subset of patients who have attended the Primary Care (PC) office with reflux symptoms during a retrospective period of 4 months (Index Visit) are invited to complete health survey questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order to assess the type, intensity and frequency of GERD symptoms at both visits and describe the treatment provided. Additionally, the impact of GERD on subjects' life, productivity and willingness to pay for GERD symptom relief will be explored. This design will give a "real-life" clinical practice picture in a representative population of PC doctors and subjects.

Study Overview

Status

Completed

Conditions

GERD

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Edmonton, Alberta, Canada
    - Research Site
  - Spruce Grove, Alberta, Canada
    - Research Site
- British Columbia
  - North Vancouver, British Columbia, Canada
    - Research Site
- Nova Scotia
  - Windsor, Nova Scotia, Canada
    - Research Site
- Ontario
  - Cornwall, Ontario, Canada
    - Research Site
  - Exeter, Ontario, Canada
    - Research Site
  - Hamilton, Ontario, Canada
    - Research Site
  - Kanata, Ontario, Canada
    - Research Site
  - London, Ontario, Canada
    - Research Site
  - Nepean, Ontario, Canada
    - Research Site
  - Newmarket, Ontario, Canada
    - Research Site
  - North Bay, Ontario, Canada
    - Research Site
  - Ottawa, Ontario, Canada
    - Research Site
  - St Catharines, Ontario, Canada
    - Research Site
  - Woodstock, Ontario, Canada
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects attending PC offices with reflux symptoms. Subjects must not have participated in any other clinical study in the time window between the Index Visit and Visit 1.

Description

Inclusion Criteria:

Provision of informed consent
Ability to complete PRO instruments (non-applicable to "non-attendees")
Subject with GERD symptom(s). At least presence of troublesome heartburn and/or regurgitation even if not specifically recorded at the Index Visit.
At least one visit during the Retrospective Visit Period (-6 to -2 months prior to study start).

In the reasons for the Index Visit section of the medical record mention of acid regurgitation and/or heartburn symptom(s) or GERD diagnosis or GERD complications has to be explicit or a treatment decision (prescription) in a previously diagnosed subject although no mention of symptoms is made.

Exclusion Criteria:

Prophylactic PPI use to reduce the risk of ulcers in subjects being treated with NSAIDs
PPI treatment to heal an ulcer induced by NSAID treatment
PPI treatment for H-pylori eradication
Participation in any other clinical study in the time window between the Index Visit and Visit 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To describe the impact of reflux symptoms on subjects' daily life Time Frame: Assessed by means of the patient reported outcomes (PROs)	Assessed by means of the patient reported outcomes (PROs)

Secondary Outcome Measures

Outcome Measure	Time Frame
To describe the impact of reflux symptoms on work productivity Time Frame: Assessed by means of the patient reported outcomes (PROs)	Assessed by means of the patient reported outcomes (PROs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria