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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00634023

Acronym

RANGE

Enrollment

500

Registered

2008-03-12

Start date

2008-01-31

Completion date

2008-05-31

Last updated

2009-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

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.

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results