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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: AZD3355; Drug: placebo

• Registration Number: NCT01043185
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-04-08
• Status Verified: 2011-05
• Results First Submitted QC: 2011-05-13
• Last Update Submitted: 2011-05-13
• Results First Posted: 2011-06-14
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	AZD3355	AZD3355 30 mg
C	AZD3355	AZD3355 120 mg
D	AZD3355	AZD3355 240 mg
E	placebo	Placebo
B	AZD3355	AZD3355 90 mg

Primary Outcome Measures

Name	Time	Method
Total Number of Reflux Episodes During 24 Hours	Measured during 24 hours at 4 different visits with a 7-28 days interval between	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)

Secondary Outcome Measures

Name	Time	Method
Number of Weakly Acidic Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.
Number of Weakly Alkaline Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.
Number of Acid Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Oklahoma City, Oklahoma, United States