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Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms

NCT ID: NCT00703534

Last Updated: 2011-06-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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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).

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Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI

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Detailed Description

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Conditions

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GERD Acid Reflux Disease Heartburn Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD3355

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks

Gelusil®

Intervention Type DRUG

Chewable tablets taken as needed

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsule. administered as a single dose twice daily for 4 weeks

Gelusil®

Intervention Type DRUG

Chewable tablets taken as needed

Interventions

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AZD3355

Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks

Intervention Type DRUG

Placebo

capsule. administered as a single dose twice daily for 4 weeks

Intervention Type DRUG

Gelusil®

Chewable tablets taken as needed

Intervention Type DRUG

Other Intervention Names

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Lesogaberan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Debra Silberg, MD

Role: STUDY_DIRECTOR

AstraZeneca

Nimish Vakil, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora Health Center/Waukesha

Locations

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Athens, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Sherwood, Arkansas, United States

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Anaheim, California, United States

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Los Angeles, California, United States

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Monterey, California, United States

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Murrieta, California, United States

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Orange, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Colorado Springs, Colorado, United States

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Pueblo, Colorado, United States

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Boynton Beach, Florida, United States

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DeLand, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Lauderdale Lakes, Florida, United States

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Miami, Florida, United States

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New Smyrna Beach, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Stockbridge, Georgia, United States

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Chicago, Illinois, United States

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Arkansas City, Kansas, United States

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Newton, Kansas, United States

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Wichita, Kansas, United States

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Madisonville, Kentucky, United States

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Monroe, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Chevy Chase, Maryland, United States

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Columbia, Maryland, United States

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Elkridge, Maryland, United States

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Hollywood, Maryland, United States

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Brockton, Massachusetts, United States

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Chesterfield, Michigan, United States

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Biloxi, Mississippi, United States

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Jackson, Mississippi, United States

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Jefferson City, Missouri, United States

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Las Vegas, Nevada, United States

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Great Neck, New York, United States

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New York, New York, United States

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Asheville, North Carolina, United States

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Elkin, North Carolina, United States

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Fayetteville, North Carolina, United States

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Greensboro, North Carolina, United States

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Harrisburg, North Carolina, United States

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Morgantown, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Canton, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Duncansville, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Anderson, South Carolina, United States

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Simpsonville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Charlottesville, Virginia, United States

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Chesapeake, Virginia, United States

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Christiansburg, Virginia, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Milwaukee, Wisconsin, United States

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Waukesha, Wisconsin, United States

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West End, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27712711 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25304129 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23919738 (View on PubMed)

Other Identifiers

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D9120C00027

Identifier Type: -

Identifier Source: org_study_id

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