EUCTR2006-000574-69-DK
Active, Not Recruiting
Phase 1
Development of an algorithm for identification of responders to short term treatment with esomeprazol (Nexium) in primary care. - PPI Response Trial
AstraZeneca A/S0 sitesMarch 22, 2006
Conditionsacid related disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- acid related disease
- Sponsor
- AstraZeneca A/S
- Status
- Active, Not Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Attend general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid\-inhibiting agent.
- •2\.Provision of written informed consent.
- •3\.Age \= 18 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Symptoms indicating Irritable Bowel Syndrome (IBS) as judged by the investigator.
- •2\.Any alarm symptoms such as significant unintended weight loss, vomiting, dysphagia, hematemesis, melena, fever, jaundice or any other signs indicating serious or malignant disease.
- •3\.Treatment with medication for all acid related symptoms and / or peptic ulcer disease. Any such treatment must be stopped before the patient enters the study.
- •4\.Treatment with proton pump inhibitors within 2 weeks prior to visit 1\.
- •5\.Treatment with medication that could interact with esomeprazole, e.g. diazepam, phenytoin and warfarin.
- •6\.Past or present disease likely to interfere with the evaluation of the study results.
- •7\.Known or suspected allergy to esomeprazole.
- •8\.Women, who are pregnant, breast feeding, or planning a pregnancy during the study.
- •9\.Women of childbearing potential, unless they maintain adequate contraception (intrauterine device, surgical sterilisation or hormonal contraception).
- •10\.Alcohol\- or drug abuse or any conditions (e.g. mental illness or dementia) associated with poor compliance.
Outcomes
Primary Outcomes
Not specified
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