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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
EUDRACT No 2006-003541-16
Secondary ID [2] 0 0
D9120C00011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease (GERD) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Twice daily during the last seven days on treatment
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
An interval of one to two hours after the first intake of AZD3355 65 mg capsule

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
Minimum age
17 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Eupen
Country [3] 0 0
Belgium
State/province [3] 0 0
Wilrijk
Country [4] 0 0
France
State/province [4] 0 0
Ales
Country [5] 0 0
France
State/province [5] 0 0
Angers
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Nantes
Country [9] 0 0
Germany
State/province [9] 0 0
Koblenz
Country [10] 0 0
Germany
State/province [10] 0 0
Koln
Country [11] 0 0
Germany
State/province [11] 0 0
Ludwigshafen
Country [12] 0 0
Germany
State/province [12] 0 0
Munchen
Country [13] 0 0
Germany
State/province [13] 0 0
Oelde
Country [14] 0 0
Germany
State/province [14] 0 0
Potsdam
Country [15] 0 0
Germany
State/province [15] 0 0
Wangen
Country [16] 0 0
Germany
State/province [16] 0 0
Wiesbaden
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
Hungary
State/province [18] 0 0
Gyor
Country [19] 0 0
Hungary
State/province [19] 0 0
Nagykanizsa
Country [20] 0 0
Hungary
State/province [20] 0 0
Pecs
Country [21] 0 0
Hungary
State/province [21] 0 0
Siofok
Country [22] 0 0
Hungary
State/province [22] 0 0
Szeged
Country [23] 0 0
Hungary
State/province [23] 0 0
Szombathely
Country [24] 0 0
Hungary
State/province [24] 0 0
VAC
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Norway
State/province [26] 0 0
Alesund
Country [27] 0 0
Norway
State/province [27] 0 0
Bergen
Country [28] 0 0
Norway
State/province [28] 0 0
Levanger
Country [29] 0 0
Norway
State/province [29] 0 0
Oslo
Country [30] 0 0
Norway
State/province [30] 0 0
RUD
Country [31] 0 0
Norway
State/province [31] 0 0
Stavanger
Country [32] 0 0
Norway
State/province [32] 0 0
Tromso
Country [33] 0 0
Norway
State/province [33] 0 0
Trondheim
Country [34] 0 0
Romania
State/province [34] 0 0
Brasov
Country [35] 0 0
Romania
State/province [35] 0 0
Bucharest
Country [36] 0 0
Romania
State/province [36] 0 0
Satu-mare
Country [37] 0 0
Romania
State/province [37] 0 0
Targu Mures

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00394472
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Göran Hasselgren, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00394472