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

This study has been completed.
Sponsor:
Collaborator:
i3 Innovus
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00795093
First received: November 20, 2008
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition
Gastroesophageal Reflux Disease (GERD)

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use [ Time Frame: Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months) ] [ Designated as safety issue: No ]
  • Utility values [ Time Frame: Collected at enrollment visit and at 6 month follow-up. ] [ Designated as safety issue: No ]

Enrollment: 552
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
552 GERD patients, partial responders to PPI treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795093

  Show 53 Study Locations
Sponsors and Collaborators
AstraZeneca
i3 Innovus
Investigators
Principal Investigator: Meg Good i3 Innovus
Study Director: Marie Sundin AstraZeneca
  More Information

No publications provided

Responsible Party: Debra Silberg, MD PhD, Medical Science Director, Clinical Research, AstraZeneca R&D
ClinicalTrials.gov Identifier: NCT00795093     History of Changes
Other Study ID Numbers: D9120N00005
Study First Received: November 20, 2008
Last Updated: May 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
GERD
PPI
partial responders

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013