A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.
The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg).
The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-blind, Multicentre Dose-finding Phase IIb Study for up to 8 Weeks' Treatment With AZD0865 25, 50, 75 mg and Esomeprazole 40 mg, Given Orally Once Daily for the Healing of Erosive Esophagitis in Adult Subjects With GERD With Erosive Esophagitis According to the LA Classification in Adult Subjects.|
- Healing of erosive esophagitis at 4 weeks.
- Healing of erosive esophagitis at 2 and 8 weeks.
- 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).
|Study Start Date:||May 2004|
|Study Completion Date:||March 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206245
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