Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
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.
2 other identifiers
interventional
244
8 countries
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2006
CompletedFirst Posted
Study publicly available on registry
November 1, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedResults Posted
Study results publicly available
March 18, 2013
CompletedMarch 18, 2013
February 1, 2013
7 months
October 31, 2006
August 11, 2011
February 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 Outcomes (1)
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
An interval of one to two hours after the first intake of AZD3355 65 mg capsule
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (38)
Research Site
Adelaide, Australia
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Brussels, Belgium
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Eupen, Belgium
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Wilrijk, Belgium
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Alès, France
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Angers, France
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Bordeaux, France
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Lyon, France
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Nantes, France
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Cologne, Germany
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Koblenz, Germany
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Ludwigshafen, Germany
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München, Germany
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Oelde, Germany
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Potsdam, Germany
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Wangen, Germany
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Wiesbaden, Germany
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Budapest, Hungary
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Győr, Hungary
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Nagykanizsa, Hungary
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Pécs, Hungary
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Siófok, Hungary
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Szeged, Hungary
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Szombathely, Hungary
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Vác, Hungary
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Amsterdam, Netherlands
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Ålesund, Norway
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Bergen, Norway
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Levanger, Norway
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Oslo, Norway
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Rud, Norway
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Stavanger, Norway
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Tromsø, Norway
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Trondheim, Norway
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Brasov, Romania
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Bucharest, Romania
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Satu Mare, Romania
Research Site
Târgu Mureş, Romania
Related Publications (1)
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.
PMID: 21402616DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Göran Hasselgren, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Guy Boeckxstaens, MD
Academisch Medisch Centrum Universiteit van Amsterdam
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2006
First Posted
November 1, 2006
Study Start
November 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
March 18, 2013
Results First Posted
March 18, 2013
Record last verified: 2013-02