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Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

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ClinicalTrials.gov Identifier: NCT00394472
Recruitment Status : Completed
First Posted : November 1, 2006
Results First Posted : March 18, 2013
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Drug: AZD3355 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : November 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Intervention Details:
  • Drug: AZD3355
    Other Name: Lesogaberan

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394472


Locations
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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
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Study Director: Göran Hasselgren, MD AstraZeneca
Principal Investigator: Guy Boeckxstaens, MD Academisch Medisch Centrum Universiteit van Amsterdam
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00394472    
Other Study ID Numbers: D9120C00011
EUDRACT No 2006-003541-16
First Posted: November 1, 2006    Key Record Dates
Results First Posted: March 18, 2013
Last Update Posted: March 18, 2013
Last Verified: February 2013
Keywords provided by AstraZeneca:
Heartburn
Patient reported symptoms
Proton pump inhibitor
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
 Intestinal Diseases
Stomach Diseases
Lesogaberan
Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs