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

GERD Clinical Trial

— RANGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634023
• Other study ID #: D9612L00113
• Status: Completed
• Phase: N/A
• First received: March 5, 2008
• Last updated: March 10, 2009
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Locations

Country	Name	City	State
Canada	Research Site	Cornwall	Ontario
Canada	Research Site	Edmonton	Alberta
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	North Vancouver	British Columbia
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Spruce Grove	Alberta
Canada	Research Site	St Catharines	Ontario
Canada	Research Site	Windsor	Nova Scotia
Canada	Research Site	Woodstock	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the impact of reflux symptoms on subjects' daily life		Assessed by means of the patient reported outcomes (PROs)	No
Secondary	To describe the impact of reflux symptoms on work productivity		Assessed by means of the patient reported outcomes (PROs)	No