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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)

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. Identifier: NCT00795093
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : May 11, 2010
i3 Innovus
Information provided by:

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.

Condition or disease
Gastroesophageal Reflux Disease (GERD)

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Study Type : Observational
Actual Enrollment : 552 participants
Observational Model: Cohort
Official Title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
Study Start Date : November 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

552 GERD patients, partial responders to PPI treatment

Primary Outcome Measures :
  1. 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) ]
  2. Utility values [ Time Frame: Collected at enrollment visit and at 6 month follow-up. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

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

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 identifier (NCT number): NCT00795093

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Sponsors and Collaborators
i3 Innovus
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Principal Investigator: Meg Good i3 Innovus
Study Director: Marie Sundin AstraZeneca

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Responsible Party: Debra Silberg, MD PhD, Medical Science Director, Clinical Research, AstraZeneca R&D Identifier: NCT00795093     History of Changes
Other Study ID Numbers: D9120N00005
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: May 11, 2010
Last Verified: May 2010
Keywords provided by AstraZeneca:
partial responders
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases