GERD With Erosive Esophagitis
Conditions
Keywords
GERD with erosive esophagitis
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.
Interventions
DRUGAZD0865
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of erosive esophagitis at 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Quality of Life in Reflux and Dyspepsia (QOLRAD). | — |
| Patient-reported symptoms. | — |
| Investigator-reported symptoms. | — |
| Healing of erosive esophagitis at 2 and 8 weeks. | — |
| pH monitoring. | — |
| Histology. | — |
| Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination). | — |
| Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F). | — |
Countries
Canada, Denmark, Finland, France, Germany, Italy, Norway, Sweden, United Kingdom, United States
Outcome results
None listed