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A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis. | Clinical Trials | Clareo Health

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

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.

NCT00206245•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (202)

Research Site

Alabaster, Alabama, United States

Research Site

Huntsville, Alabama, United States

Research Site

Tucson, Arizona, United States

Research Site

North Little Rock, Arkansas, United States

Research Site

Anaheim, California, United States

Research Site

Cypress, California, United States

Research Site

Garden Grove, California, United States

Research Site

Lancaster, California, United States

Research Site

Los Angeles, California, United States

Research Site

Mission Hills, California, United States

Key Dates

Start Date

May 1, 2004

Completion Date

March 1, 2005

Last Updated

January 4, 2013

Enrollment

1,400

Estimated participants

Conditions

GERD With Erosive Esophagitis

Interventions

AZD0865

DRUG