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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206245
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 4, 2013
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Brief Summary:

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 or disease Intervention/treatment Phase
GERD With Erosive Esophagitis Drug: AZD0865 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : May 2004
Actual Study Completion Date : March 2005

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

Secondary Outcome Measures :
  1. Healing of erosive esophagitis at 2 and 8 weeks.
  2. The Quality of Life in Reflux and Dyspepsia (QOLRAD).
  3. Patient-reported symptoms.
  4. Investigator-reported symptoms.
  5. Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
  6. pH monitoring.
  7. Histology.
  8. Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.
  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00206245

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Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00206245    
Other Study ID Numbers: D9770C00012
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
GERD with erosive esophagitis
Additional relevant MeSH terms:
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Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases