Status:
COMPLETED
Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With GERD
Lead Sponsor:
AstraZeneca
Conditions:
GERD
Eligibility:
All Genders
18+ years
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00634023
Start Date
January 1 2008
End Date
May 1 2008
Last Update
March 11 2009
Active Locations (15)
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1
Research Site
Edmonton, Alberta, Canada
2
Research Site
Spruce Grove, Alberta, Canada
3
Research Site
North Vancouver, British Columbia, Canada
4
Research Site
Windsor, Nova Scotia, Canada