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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

AZD3355 30 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

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

B

AZD3355 90 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

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

C

AZD3355 120 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

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

D

AZD3355 240 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

240 mg orally in the morning and 240 mg in the evening for 1 day

E

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Interventions

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AZD3355

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

Intervention Type DRUG

AZD3355

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

Intervention Type DRUG

AZD3355

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

Intervention Type DRUG

AZD3355

240 mg orally in the morning and 240 mg in the evening for 1 day

Intervention Type DRUG

placebo

Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No