Skip to main content
OpenTrials
Completed

NCT Number: NCT00634023

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To describe the impact of reflux symptoms on subjects' daily life

    Time frame: Assessed by means of the patient reported outcomes (PROs)

Secondary outcomes

  1. To describe the impact of reflux symptoms on work productivity

    Time frame: Assessed by means of the patient reported outcomes (PROs)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: RANGE

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2008
Registry last updated
Mar 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.