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

May 13, 2011 updated by: AstraZeneca

A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: E
Placebo
Drug: placebo
Placebo capsules orally in the morning and placebo capsules in the evening for 1 day
Experimental: A
AZD3355 30 mg
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
Experimental: B
AZD3355 90 mg
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
Experimental: C
AZD3355 120 mg
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
Experimental: D
AZD3355 240 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Reflux Episodes During 24 Hours
Time Frame: 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)
Measured during 24 hours at 4 different visits with a 7-28 days interval between

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Acid Reflux Episodes
Time Frame: 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.
Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of Weakly Acidic Reflux Episodes
Time Frame: 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.
Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of Weakly Alkaline Reflux Episodes
Time Frame: 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.
Measured during 24 hours at 4 different visits with a 7-28 days interval between

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Philip Miner, Oklahoma Foundation of Digestive Research
  • Study Director: Debra G Silberg, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9120C00032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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