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A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 15, 2005
Last updated: January 3, 2013
Last verified: January 2013
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 20 mg and to evaluate the safety and tolerability of AZD0865.

Condition Intervention Phase
GERD Without Erosive Esophagitis Drug: AZD0865 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to sustained absence of patient-reported heartburn.

Secondary Outcome Measures:
  • 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.
  • Histology.
  • Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).

Estimated Enrollment: 1400
Study Start Date: May 2004
Study Completion Date: April 2005

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone.
  • Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1.
  • Have an absence of mucosal breaks in the esophagus, as defined by the LA classification, at the visit 1 endoscopy.
  • Have provided Informed consent.

Exclusion Criteria:

Subjects with current or historical evidence of the following conditions are excluded from the study:

  • Erosive esophagitis.
  • Esophageal columnar metaplasia (Barrett's esophagus) of 1.0 cm or greater.
  • Esophageal stricture.
  • Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
  • Systemic Sclerosis (scleroderma).
  • Irritable Bowel Syndrome (IBS), i.e. upper abdominal discomfort or pain that in the opinion of the Investigator is likely to be due to IBS or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools.
  • Inflammatory bowel disease.
  • Zollinger-Ellison syndrome.
  • Gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months

Subjects with i) history of significant or ii) current significant or unstable:

  • Cardiovascular diseases or cardiac chest pain.
  • Cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus.
  • Diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable.
  • Pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study.
  • Malignant disease (except for minor superficial skin disease).
  • Generalised bleeding disorders.
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Please refer to this study by its identifier: NCT00206284

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Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00206284     History of Changes
Other Study ID Numbers: D9770C00011
Study First Received: September 15, 2005
Last Updated: January 3, 2013

Keywords provided by AstraZeneca:
GERD without erosive esophagitis

Additional relevant MeSH terms:
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017