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

Completed

• Conditions: GERD

• Registration Number: NCT00634023
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-12
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-10
• Last Update Posted: 2009-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the impact of reflux symptoms on subjects' daily life	Assessed by means of the patient reported outcomes (PROs)

Secondary Outcome Measures

Name	Time	Method
To describe the impact of reflux symptoms on work productivity	Assessed by means of the patient reported outcomes (PROs)

Trial Locations

Locations (1)

Research Site; 🇨🇦 Woodstock, Ontario, Canada