A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
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|ClinicalTrials.gov Identifier: NCT00206284|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|GERD Without Erosive Esophagitis||Drug: AZD0865||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A 4-week, Randomised, Double-blind, Multicentre, Dose-finding Phase IIb Study With AZD0865 25, 50, 75 mg and Esomeprazole 20 mg, Given Orally Once Daily for the Treatment of GERD Without Erosive Esophagitis According to the LA Classification in Adult Subjects.|
|Study Start Date :||May 2004|
|Actual Study Completion Date :||April 2005|
- Time to sustained absence of patient-reported heartburn.
- The Quality of Life in Reflux and Dyspepsia (QOLRAD).
- Patient-reported symptoms.
- Investigator-reported symptoms.
- Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
- pH monitoring.
- Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).
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): NCT00206284
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