Clinical trial NCT00703534: Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
Official title: Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: GERD
Acid Reflux Disease
Heartburn
Regurgitation
Keywords: GERD
Acid Reflux
Heartburn
Regurgitation
non-acid reflux
PRO measures
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).


Eligibility criteria: Inclusion Criteria:

* Subject able to read and write US english and able to use electronic devices
* Subjects who have experienced GERD symptoms for at least six months
* Subjects currently taking a prescription or over-the-counter PPI medications for GERD
* Body Mass Index (BMI) 18.5-35.0, inclusive

Exclusion Criteria:

* Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment
* Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
* Prior surgery of the upper Gastrointestinal (GI) tract

Primary outcomes:
measure: Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
timeFrame: Run-in period of 8-12 days and treatment period of 26-30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Sherwood
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Monterey
country: United States
facility: Research Site
state: California
city: Murrieta
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Pueblo
country: United States
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state: Colorado
city: Boynton Beach
country: United States
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state: Florida
city: Deland
country: United States
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state: Florida
city: Hialeah
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jupiter
country: United States
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state: Florida
city: Lauderdale Lakes
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: New Smyrna Beach
country: United States
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state: Florida
city: Pembroke Pines
country: United States
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state: Florida
city: Port Orange
country: United States
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state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Zephyrhills
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
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state: Illinois
city: Arkansas City
country: United States
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state: Kansas
city: Newton
country: United States
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state: Kansas
city: Wichita
country: United States
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state: Kansas
city: Madisonville
country: United States
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state: Kentucky
city: Monroe
country: United States
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state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Chevy Chase
country: United States
facility: Research Site
state: Maryland
city: Columbia
country: United States
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state: Maryland
city: Elkridge
country: United States
facility: Research Site
state: Maryland
city: Hollywood
country: United States
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state: Maryland
city: Brockton
country: United States
facility: Research Site
state: Massachusetts
city: Chesterfield
country: United States
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state: Michigan
city: Biloxi
country: United States
facility: Research Site
state: Mississippi
city: Jackson
country: United States
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state: Mississippi
city: Jefferson City
country: United States
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state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Great Neck
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Elkin
country: United States
facility: Research Site
state: North Carolina
city: Fayetteville
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Harrisburg
country: United States
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state: North Carolina
city: Morgantown
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-salem
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Harrisburg
country: United States
facility: Research Site
state: Pennsylvania
city: Sayre
country: United States
facility: Research Site
state: Pennsylvania
city: Cranston
country: United States
facility: Research Site
state: Rhode Island
city: Anderson
country: United States
facility: Research Site
state: South Carolina
city: Simpsonville
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Germantown
country: United States
facility: Research Site
state: Tennessee
city: Jackson
country: United States
facility: Research Site
state: Tennessee
city: Johnson City
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Christiansburg
country: United States
facility: Research Site
state: Virginia
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Waukesha
country: United States
facility: Research Site
state: Wisconsin
city: West End
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Debra Silberg, MD
role: STUDY_DIRECTOR
affiliation: Aurora Health Center/Waukesha
name: Nimish Vakil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryden A, Leavy OC, Halling K, Stone AA. Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy. Value Health. 2016 Sep-Oct;19(6):829-833. doi: 10.1016/j.jval.2016.05.007. Epub 2016 Jun 29.
citation: Vakil N, Niklasson A, Denison H, Ryden A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naive patients with gastroesophageal reflux disease: a post hoc analysis of two study populations. BMC Gastroenterol. 2014 Oct 10;14:177. doi: 10.1186/1471-230X-14-177.
citation: Ryden A, Denison H, Karlsson M, Vakil N. Development and validation of a patient-reported outcome instrument in partial responders to proton pump inhibitors. Scand J Gastroenterol. 2013 Sep;48(9):1018-26. doi: 10.3109/00365521.2013.822544. Epub 2013 Aug 6.