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

NCT00703534 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2011-06-20

Study results available
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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

Interventions

DRUG

AZD3355

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

DRUG

Placebo

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

DRUG

Gelusil®

Chewable tablets taken as needed

Sponsors & Collaborators

Principal Investigators

  • Debra Silberg, MD · AstraZeneca

  • Nimish Vakil, MD · Aurora Health Center/Waukesha

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703534 on ClinicalTrials.gov