Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

February 14, 2013 updated by: AstraZeneca

A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.

The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

Study Overview

Status

Completed

Conditions

Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment

Drug: AZD3355

Study Type

Interventional

Enrollment (Actual)

244

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

Australia
- - Adelaide, Australia
    - Research Site
Belgium
- - Brussels, Belgium
    - Research Site
  - Eupen, Belgium
    - Research Site
  - Wilrijk, Belgium
    - Research Site
France
- - Ales, France
    - Research Site
  - Angers, France
    - Research Site
  - Bordeaux, France
    - Research Site
  - Lyon, France
    - Research Site
  - Nantes, France
    - Research Site
Germany
- - Koblenz, Germany
    - Research Site
  - Koln, Germany
    - Research Site
  - Ludwigshafen, Germany
    - Research Site
  - Munchen, Germany
    - Research Site
  - Oelde, Germany
    - Research Site
  - Potsdam, Germany
    - Research Site
  - Wangen, Germany
    - Research Site
  - Wiesbaden, Germany
    - Research Site
Hungary
- - Budapest, Hungary
    - Research Site
  - Gyor, Hungary
    - Research Site
  - Nagykanizsa, Hungary
    - Research Site
  - Pecs, Hungary
    - Research Site
  - Siofok, Hungary
    - Research Site
  - Szeged, Hungary
    - Research Site
  - Szombathely, Hungary
    - Research Site
  - VAC, Hungary
    - Research Site
Netherlands
- - Amsterdam, Netherlands
    - Research Site
Norway
- - Alesund, Norway
    - Research Site
  - Bergen, Norway
    - Research Site
  - Levanger, Norway
    - Research Site
  - Oslo, Norway
    - Research Site
  - RUD, Norway
    - Research Site
  - Stavanger, Norway
    - Research Site
  - Tromso, Norway
    - Research Site
  - Trondheim, Norway
    - Research Site
Romania
- - Brasov, Romania
    - Research Site
  - Bucharest, Romania
    - Research Site
  - Satu-mare, Romania
    - Research Site
  - Targu Mures, Romania
    - 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

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Provision of written informed consent
At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms
Continuous treatment with Proton Pump Inhibitor (PPI)
Ability to read and write

Exclusion Criteria:

Prior surgery of the upper gastrointestinal (GI) tract
History of clinically significant diseases other than GERD
Need for concomitant medication with drugs that may influence gastrointestinal symptoms

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: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment Time Frame: Twice daily during the last seven days on treatment	Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary	Twice daily during the last seven days on treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule Time Frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule	An interval of one to two hours after the first intake of AZD3355 65 mg capsule

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

Study Director: Göran Hasselgren, MD, AstraZeneca
Principal Investigator: Guy Boeckxstaens, MD, Academisch Medisch Centrum Universiteit van Amsterdam

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

Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Bjorck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.

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

November 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)