Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With GERD - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00634023

Purpose

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.

Condition
GERD

Study Type:	Observational
Study Design:	Cross-Sectional
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: GERD

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To describe the impact of reflux symptoms on subjects' daily life [ Time Frame: Assessed by means of the patient reported outcomes (PROs) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe the impact of reflux symptoms on work productivity [ Time Frame: Assessed by means of the patient reported outcomes (PROs) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

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

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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634023

Locations

Canada, Alberta
Research Site
EDMONTON, Alberta, Canada
Research Site
SPRUCE GROVE, Alberta, Canada
Canada, British Columbia
Research Site
NORTH VANCOUVER, British Columbia, Canada
Canada, Nova Scotia
Research Site
WINDSOR, Nova Scotia, Canada
Canada, Ontario
Research Site
CORNWALL, Ontario, Canada
Research Site
EXETER, Ontario, Canada
Research Site
HAMILTON, Ontario, Canada
Research Site
WOODSTOCK, 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
KANATA, Ontario, Canada

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9612L00113
Study First Received:	March 5, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00634023 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on September 10, 2009