Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00795093

Acronym

REMAIN

Enrollment

552

Registered

2008-11-21

Start date

2008-11-30

Completion date

2010-01-31

Last updated

2010-05-11

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

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERD, PPI, partial responders

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 6 month history of GERD symptoms * Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period * Remaining GERD symptoms despite optimized PPI treatment * Able to read and write in US English, 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

Design outcomes

Primary

Measure	Time frame
Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use	Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)
Utility values	Collected at enrollment visit and at 6 month follow-up.

Countries

United States

Outcome results