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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00394472
Registration number
NCT00394472
Ethics application status
Date submitted
31/10/2006
Date registered
1/11/2006
Date last updated
18/03/2013
Titles & IDs
Public title
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
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Scientific 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.
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Secondary ID [1]
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EUDRACT No 2006-003541-16
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Secondary ID [2]
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D9120C00011
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease (GERD)
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD3355
Treatment: Drugs: AZD3355
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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
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Timepoint [1]
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Twice daily during the last seven days on treatment
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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An interval of one to two hours after the first intake of AZD3355 65 mg capsule
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Eligibility
Key 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
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Minimum age
17
Years
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2007
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Sample size
Target
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Accrual to date
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Final
244
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
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Belgium
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Brussels
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Belgium
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Eupen
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Belgium
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Wilrijk
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France
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Ales
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France
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Angers
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France
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Bordeaux
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France
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Lyon
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France
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Nantes
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Germany
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Koblenz
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Germany
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Koln
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Germany
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Ludwigshafen
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Germany
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Munchen
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Germany
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Oelde
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Germany
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Potsdam
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Germany
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Wangen
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Germany
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Wiesbaden
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Nagykanizsa
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Hungary
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Pecs
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Hungary
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Siofok
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Hungary
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Szeged
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VAC
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Netherlands
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Amsterdam
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Norway
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Alesund
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Norway
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Bergen
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Norway
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Levanger
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Norway
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Oslo
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Norway
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RUD
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Norway
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Stavanger
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Norway
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Tromso
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Norway
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Trondheim
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Satu-mare
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Romania
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Targu Mures
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00394472
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Göran Hasselgren, MD
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Address
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00394472
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