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

Phase 2

Completed

• Conditions: GERD; Acid Reflux Disease; Heartburn; Regurgitation
• Interventions: Drug: AZD3355; Drug: Placebo; Drug: Gelusil®

• Registration Number: NCT00703534
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-23
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2011-02-04
• Status Verified: 2011-05
• Results First Submitted QC: 2011-05-20
• Last Update Submitted: 2011-05-20
• Results First Posted: 2011-06-20
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 478

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD3355	AZD3355	-
AZD3355	Gelusil®	-
Placebo	Placebo	-
Placebo	Gelusil®	-

Primary Outcome Measures

Name	Time	Method
Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary	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)

Trial Locations

Locations (1)

Research Site; 🇺🇸 West End, Wisconsin, United States