Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France

The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.

Completed

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Key information

Conditions

Gastroesophageal Reflux Disease 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, Bandol, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

At least 6 month history of GERD symptoms
Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment
Remaining GERD symptoms despite optimized PPI treatment
Able to read and write in French, and able to comply with study requirements

Exclusion criteria

Patients that have not experienced any GERD symptom improvement at all during PPI treatment
Involvement in the planning or conduct of the study
Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
Prior surgery of the upper GI tract

Treatment and study plan

Primary outcomes

Productivity loss; Frequency and severity of GERD symptoms; Health care resource use

Time frame: Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up)
Utility values; Quality of Life

Time frame: Collected at enrollment visit and at 6 and 12 month follow-up.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

i3 Innovus

Registry information

Official study title

Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

Acronym: REMAIN

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Feb 12, 2009
Registry last updated: Feb 7, 2011

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.

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

Completed