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

NCT01043185 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-06-14

Study results available
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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.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

AZD3355

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

DRUG

AZD3355

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

DRUG

AZD3355

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

DRUG

AZD3355

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

DRUG

placebo

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

Sponsors & Collaborators

Principal Investigators

  • Philip Miner · Oklahoma Foundation of Digestive Research

  • Debra G Silberg · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01043185 on ClinicalTrials.gov