Skip to main content
OpenTrials
Completed

NCT Number: NCT00703534

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

GERD Acid Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Regurgitation Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Athens, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3355

Drug

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

Other names: Lesogaberan

Placebo

Drug

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

Gelusil®

Drug

Chewable tablets taken as needed

Primary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: C27

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2008
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.