Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

AstraZeneca244 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

244

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

AZD3355DRUG

Eligibility

Sex: ALLMin age: 17 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (38)

Research Site

Outcomes

Primary Outcomes

Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment

Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary

Time frame: Twice daily during the last seven days on treatment

Secondary Outcomes

Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule

Time frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.