Back to resultsA Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
Primary Purpose
GERD Without Erosive Esophagitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD0865
Sponsored by
About this trial
This is an interventional treatment trial for GERD Without Erosive Esophagitis focused on measuring GERD without erosive esophagitis
Eligibility Criteria
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. 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 Criteria: 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.
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Outcomes
Primary Outcome Measures
Time to sustained absence of patient-reported heartburn.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00206284
Brief Title
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
Official Title
A 4-week, Randomised, Double-blind, Multicentre, Dose-finding Phase IIb Study With AZD0865 25, 50, 75 mg and Esomeprazole 20 mg, Given Orally Once Daily for the Treatment of GERD Without Erosive Esophagitis According to the LA Classification in Adult Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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 20 mg and to evaluate the safety and tolerability of AZD0865.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD Without Erosive Esophagitis
Keywords
GERD without erosive esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD0865
Primary Outcome Measure Information:
Title
Time to sustained absence of patient-reported heartburn.
Secondary Outcome Measure Information:
Title
The Quality of Life in Reflux and Dyspepsia (QOLRAD).
Title
Patient-reported symptoms.
Title
Investigator-reported symptoms.
Title
Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
Title
pH monitoring.
Title
Histology.
Title
Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 Criteria:
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.
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United Kingdom
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Research Site
City
Lancaster
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Slough
Country
United Kingdom
Facility Name
Research Site
City
Somerset
Country
United Kingdom
Facility Name
Research Site
City
Stafford
Country
United Kingdom
Facility Name
Research Site
City
Stockport
Country
United Kingdom
Facility Name
Research Site
City
Telford
Country
United Kingdom
Facility Name
Research Site
City
Torquay
Country
United Kingdom
Facility Name
Research Site
City
West Bromwich
Country
United Kingdom
Facility Name
Research Site
City
West Yorks
Country
United Kingdom
Facility Name
Research Site
City
Woking
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23831734
Citation
Kahrilas PJ, Jonsson A, Denison H, Wernersson B, Hughes N, Howden CW. Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy. Gut. 2014 May;63(5):720-6. doi: 10.1136/gutjnl-2013-304883. Epub 2013 Jul 5.
Results Reference
derived
Learn more about this trial
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
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