Status:
COMPLETED
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
Lead Sponsor:
AstraZeneca
Conditions:
GERD Without Erosive Esophagitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 esomepra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00206284
Start Date
May 1 2004
End Date
April 1 2005
Last Update
January 4 2013
Active Locations (202)
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1
Research Site
Alabaster, Alabama, United States
2
Research Site
Huntsville, Alabama, United States
3
Research Site
Tucson, Arizona, United States
4
Research Site
North Little Rock, Arkansas, United States