Clinical trial NCT00394472: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Heartburn
Patient reported symptoms
Proton pump inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-01
Enrollment: 244
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Twice daily during the last seven days on treatment
Secondary outcomes:
measure: 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
timeFrame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Eupen
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Ales
country: France
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Oelde
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Nagykanizsa
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Siofok
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: VAC
country: Hungary
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Alesund
country: Norway
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Levanger
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: RUD
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Tromso
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Satu-mare
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Göran Hasselgren, MD
role: STUDY_DIRECTOR
affiliation: Academisch Medisch Centrum Universiteit van Amsterdam
name: Guy Boeckxstaens, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.