Back to resultsSymptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
Primary Purpose
Gastroesophageal Reflux Disease (GERD)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD3355
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Heartburn, Patient reported symptoms, Proton pump inhibitor
Eligibility Criteria
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
Sites / Locations
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Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00394472
Brief Title
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
Heartburn, Patient reported symptoms, Proton pump inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD3355
Other Intervention Name(s)
Lesogaberan
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Twice daily during the last seven days on treatment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Göran Hasselgren, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, MD
Organizational Affiliation
Academisch Medisch Centrum Universiteit van Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Adelaide
Country
Australia
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Eupen
Country
Belgium
Facility Name
Research Site
City
Wilrijk
Country
Belgium
Facility Name
Research Site
City
Ales
Country
France
Facility Name
Research Site
City
Angers
Country
France
Facility Name
Research Site
City
Bordeaux
Country
France
Facility Name
Research Site
City
Lyon
Country
France
Facility Name
Research Site
City
Nantes
Country
France
Facility Name
Research Site
City
Koblenz
Country
Germany
Facility Name
Research Site
City
Koln
Country
Germany
Facility Name
Research Site
City
Ludwigshafen
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Oelde
Country
Germany
Facility Name
Research Site
City
Potsdam
Country
Germany
Facility Name
Research Site
City
Wangen
Country
Germany
Facility Name
Research Site
City
Wiesbaden
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Nagykanizsa
Country
Hungary
Facility Name
Research Site
City
Pecs
Country
Hungary
Facility Name
Research Site
City
Siofok
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Szombathely
Country
Hungary
Facility Name
Research Site
City
VAC
Country
Hungary
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Alesund
Country
Norway
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Levanger
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
RUD
Country
Norway
Facility Name
Research Site
City
Stavanger
Country
Norway
Facility Name
Research Site
City
Tromso
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Satu-mare
Country
Romania
Facility Name
Research Site
City
Targu Mures
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
21402616
Citation
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.
Results Reference
derived
Learn more about this trial
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
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