acid related disease
Conditions
Interventions
Product Name: Nexium
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: esomeprazole magnesium trihydrate
CAS Number: 217087-09-7
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
AstraZeneca A/S
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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)). 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. To describe the key complaints. To assess patient satisfaction. To asses disease impact on quality of life and certain health economic parameters. ;Primary end point(s): Efficacy 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. | — |
Countries
Denmark
Outcome results
None listed