Skip to main content
Clinical Trials/EUCTR2006-000574-69-DK
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

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.

Registry
who.int
Start Date
March 22, 2006
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AstraZeneca A/S

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

Similar Trials