Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms (C27)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Heartburn; Acid Reflux Disease; Regurgitation; GERD

Treatments: Drug: Gelusil®; Drug: AZD3355; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703534

D9120C00027

Details and patient eligibility

About

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).

Enrollment: 478 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

478 participants in 2 patient groups, including a placebo group

AZD3355

Experimental group

Treatment:

Drug: AZD3355

Drug: Gelusil®

Placebo

Placebo Comparator group

Treatment:

Drug: Gelusil®

Drug: Placebo