Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

Gastroesophageal Reflux Disease (GERD) Clinical Trial

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.

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

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