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A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 13, 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 40 mg and to evaluate the safety and tolerability of AZD0865.

Condition Intervention Phase
GERD With Erosive Esophagitis
Drug: AZD0865
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Healing of erosive esophagitis at 4 weeks.

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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  • Erosive esophagitis according to LA classification Grade A, B, C or D, 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:

  • 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
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Please refer to this study by its identifier: NCT00206245

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No publications provided by AstraZeneca

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00206245     History of Changes
Other Study ID Numbers: D9770C00012
Study First Received: September 13, 2005
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
GERD with erosive esophagitis

Additional relevant MeSH terms:
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on March 03, 2015