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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00394472
Other study ID # D9120C00011
Secondary ID EUDRACT No 2006-
Status Completed
Phase Phase 2
First received October 31, 2006
Last updated February 14, 2013
Start date November 2006
Est. completion date June 2007

Study information

Verified date February 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyRomania: National Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 244
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
AZD3355


Locations

Country Name City State
Australia Research Site Adelaide
Belgium Research Site Brussels
Belgium Research Site Eupen
Belgium Research Site Wilrijk
France Research Site Ales
France Research Site Angers
France Research Site Bordeaux
France Research Site Lyon
France Research Site Nantes
Germany Research Site 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
Hungary Research Site 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
Netherlands Research Site Amsterdam
Norway Research Site 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
Romania Research Site Brasov
Romania Research Site Bucharest
Romania Research Site Satu-mare
Romania Research Site Targu Mures

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Belgium,  France,  Germany,  Hungary,  Netherlands,  Norway,  Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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