Clinical trial NCT00634023: Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With GERD
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: To describe the impact of reflux symptoms on subjects' daily life
timeFrame: Assessed by means of the patient reported outcomes (PROs)
Secondary outcomes:
measure: To describe the impact of reflux symptoms on work productivity
timeFrame: Assessed by means of the patient reported outcomes (PROs)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Spruce Grove
country: Canada
facility: Research Site
state: Alberta
city: North Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Windsor
country: Canada
facility: Research Site
state: Nova Scotia
city: Cornwall
country: Canada
facility: Research Site
state: Ontario
city: Exeter
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kanata
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Nepean
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: North Bay
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: St Catharines
country: Canada
facility: Research Site
state: Ontario
city: Woodstock
country: Canada
facility: Research Site
state: Ontario
Study officials:
References: