Development of an algorithm for identification of responders to short term treatment with esomeprazol (Nexium) in primary care. - PPI Response Trial

Phase 1

• Conditions: acid related disease

• Registration Number: EUCTR2006-000574-69-DK
• Lead Sponsor: AstraZeneca A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-22
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
11.Treatment with any non-approved compound within the month prior to start of study medication.
12.Previous inclusion in this study at any time or participation in other clinical trials within the last month.
13.Need for an interpreter.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to develop, and test, an algorithm for a priori identification of responders to empirical esomeprazole treatment in general practice.<br>;Secondary Objective: To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).<br>To compare time to response between esomeprazole and placebo. Time to response is defined as the first day of sustained absence of the key complaint.<br>To describe the key complaints.<br>To assess patient satisfaction.<br>To asses disease impact on quality of life and certain health economic parameters.<br>;Primary end point(s): Efficacy<br>The primary efficacy variable is the patient’s key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.<br>