Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

GERD

Acid Reflux Disease

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

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

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

478 Patients enrolled

Trial Details

Trial ID

NCT00703534

Start Date

May 1 2008

End Date

January 1 2009

Last Update

June 20 2011

Active Locations (84)

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Page 1 of 21 (84 locations)

1

Research Site

Athens, Alabama, United States

2

Research Site

Tucson, Arizona, United States

3

Research Site

Little Rock, Arkansas, United States

4

Research Site

Sherwood, Arkansas, United States

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