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Canadian, Multi-Centre Study ...

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

Last Updated: 2009-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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GERD

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers