Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: AZD3355	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: GERD

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: Twice daily during the last seven days on treatment ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

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 [ Time Frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule ] [ Designated as safety issue: No ]

Enrollment:	244
Study Start Date:	November 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Lesogaberan

Eligibility

Ages Eligible for Study:	17 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394472

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Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Göran Hasselgren, MD	AstraZeneca
Principal Investigator:	Guy Boeckxstaens, MD	Academisch Medisch Centrum Universiteit van Amsterdam

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Björck 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. Epub 2011 Mar 14.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00394472 History of Changes
Other Study ID Numbers:	D9120C00011, EUDRACT No 2006-003541-16
Study First Received:	October 31, 2006
Results First Received:	August 11, 2011
Last Updated:	February 14, 2013
Health Authority:	Norway: Norwegian Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Directorate general for the protection of Public health: Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Romania: National Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Heartburn
Patient reported symptoms
Proton pump inhibitor

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013