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.
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Australia, Belgium, France, Germany, Hungary, Netherlands, Norway, Romania,
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 |
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