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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:
ClinicalTrials.gov Identifier:
NCT00795093
First Posted: November 21, 2008
Last Update Posted: May 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
i3 Innovus
Information provided by:
AstraZeneca
  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

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) ]
  • Utility values [ Time Frame: Collected at enrollment visit and at 6 month follow-up. ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 20, 2008
First Posted: November 21, 2008
Last Update Posted: May 11, 2010
Last Verified: May 2010

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