Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: AZD3355

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394472

D9120C00011

EUDRACT No 2006-003541-16

Details and patient eligibility

About

The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

Enrollment: 244 patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent
• At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms
• Continuous treatment with Proton Pump Inhibitor (PPI)
• Ability to read and write

Exclusion criteria

• Prior surgery of the upper gastrointestinal (GI) tract
• History of clinically significant diseases other than GERD
• Need for concomitant medication with drugs that may influence gastrointestinal symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind