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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Disease (GERD) | Drug: AZD3355 | Phase 2 |
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 |
- Drug: AZD3355
Other Name: Lesogaberan
- 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
- 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 ]

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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 |
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

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
Australia | |
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Adelaide, Australia | |
Belgium | |
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Brussels, Belgium | |
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Eupen, Belgium | |
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Wilrijk, Belgium | |
France | |
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Ales, France | |
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Angers, France | |
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Bordeaux, France | |
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Lyon, France | |
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Nantes, France | |
Germany | |
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Koblenz, Germany | |
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Koln, Germany | |
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Ludwigshafen, Germany | |
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Munchen, Germany | |
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Oelde, Germany | |
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Potsdam, Germany | |
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Wangen, Germany | |
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Wiesbaden, Germany | |
Hungary | |
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Budapest, Hungary | |
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Gyor, Hungary | |
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Nagykanizsa, Hungary | |
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Pecs, Hungary | |
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Siofok, Hungary | |
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Szeged, Hungary | |
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Szombathely, Hungary | |
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VAC, Hungary | |
Netherlands | |
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Amsterdam, Netherlands | |
Norway | |
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Alesund, Norway | |
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Bergen, Norway | |
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Levanger, Norway | |
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Oslo, Norway | |
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RUD, Norway | |
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Stavanger, Norway | |
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Tromso, Norway | |
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Trondheim, Norway | |
Romania | |
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Brasov, Romania | |
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Bucharest, Romania | |
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Satu-mare, Romania | |
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Targu Mures, Romania |
Study Director: | Göran Hasselgren, MD | AstraZeneca | |
Principal Investigator: | Guy Boeckxstaens, MD | Academisch Medisch Centrum Universiteit van Amsterdam |
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 |
Heartburn Patient reported symptoms Proton pump inhibitor |
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 |