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

NCT00703534 | Completed Phase 2 Results

• 1 other identifier: D9120C00027
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 84

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).

Conditions

GERD; Acid Reflux Disease; Heartburn; Regurgitation

Keywords

GERD; Acid Reflux; Heartburn; Regurgitation; non-acid reflux; PRO measures

Outcome Measures

Primary Outcomes (1)

• Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary

  Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)

  Run-in period of 8-12 days and treatment period of 26-30 days

Study Arms (2)

AZD3355

EXPERIMENTAL

Drug: AZD3355; Drug: Gelusil®

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Gelusil®

Interventions

AZD3355 DRUG

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

Also known as: Lesogaberan

AZD3355

Placebo DRUG

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

Placebo

Gelusil® DRUG

Chewable tablets taken as needed

AZD3355; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (84)

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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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Related Publications (3)

• 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.

  PMID: 27712711 DERIVED

• 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.

  PMID: 25304129 DERIVED

• 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.

  PMID: 23919738 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

lesogaberan; Gelusil

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Debra Silberg, MD

  AstraZeneca

  STUDY DIRECTOR

• Nimish Vakil, MD

  Aurora Health Center/Waukesha

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 20, 2011
• Results First Posted: June 20, 2011

Record last verified: 2011-05

Locations

US (84)