A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

AstraZeneca27 enrolled

Overview

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

AZD3355DRUG

30 mg orally in the morning and 30 mg in the evening for 1 day

AZD3355DRUG

90 mg orally in the morning and 90 mg in the evening for 1 day

AZD3355DRUG

120 mg orally in the morning and 120 mg in the evening for 1 day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provide informed consent * History of GERD with persistent symptoms despite treatment with PPI * Otherwise normal physical health Exclusion Criteria: * History of GERD with symptoms that has not improved at all during treatment with PPI * Prior surgery of the upper gastrointestinal tract * History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Locations (1)

Research Site

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Total Number of Reflux Episodes During 24 Hours

Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)

Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between

Secondary Outcomes

Number of Acid Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH \<4 (or a drop of at least 1 pH unit if pH is already \<4) lasting more than 5 s.

Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between

Number of Weakly Acidic Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.

Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between

Number of Weakly Alkaline Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.

Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between

Data from ClinicalTrials.gov

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