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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.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00206284
  Purpose

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 II

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206284

  Show 202 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

Study ID Numbers: D9770C00011
Study First Received: September 15, 2005
Last Updated: September 26, 2005
ClinicalTrials.gov Identifier: NCT00206284  
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
GERD without erosive esophagitis

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Signs and Symptoms
Esophagitis
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroenteritis
Gastroesophageal Reflux

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009