Gastroesophageal reflux disease with heartburn as predominant symptom. Treatment failure (defined as 4 days with mild symptoms or 2 days with moderate to severe symptoms during the past 7 days) with previous Proton Pump Inhibitor. MedDRA version: 8.0 Level: Low Classification code 10018203
Conditions
Interventions
Product Name: Nexium
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: esomeprazole
CAS Number: 217087-09-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg m
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Male or female, age 18-65 years 3. History of GERD symptoms during, at least, six months prior to enrolment. 4. PPI as maintenance and/or as needed treatment during the last 30 days prior to enrolment. 5. Heartburn as predominant GERD symptom, as judged by the investigator 6. Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the subject as either: 4 days with mild symptoms (i.e. awareness of sign or symptom , but easily tolerated) or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) 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. Treatment with esomeprazole during 30 days prior to enrolment 2. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer 3. Patients with current or historical evidence of the following diseases/conditions, as judged by the investigator: · Zollinger-Ellison syndrome · Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm · Gastric or duodenal ulcers within the last three months · Malabsorbtion · Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study · Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable · Patients with severe diseases or disorders which may interfere with the conduct of the study 4. Any “alarm symptoms” such as unintentional weight loss, GI bleeding, dysphagia, jaundice or any other sign indicating serious or malignant disease. 5. Patients with known history of complications of GERD such as esophageal stricture needing intervention or known significant dysplastic changes in the esophagus. 6. Patients with symptoms that in the opinion of the investigator are likely to be due to Irritable Bowel Syndrome (IBS), or subjects who fulfil two or more of the following criteria: · symptoms relieved by defecation · symptoms associated with change in frequency of stool · symptoms associated with change in form of stools 7. Patients with need of continuous concomitant therapy with · Warfarin · Drugs with antikolinergic effect · Sucralfat · Cisapride · Prostaglandin analogues · NSAIDs (sporadic use with up to 2 tabl per week is allowed) · ASA (except for 165 mg daily or less for cardiovascular prophylaxis) · H2-receptor antagonists 8. Contraindications to the study drug, e.g. known or suspected allergy to esomeprazole 9. Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator 10. Suspected poor capability to follow instructions of the study, e.g. because of difficulty to read/understand Swedish, a history of drug abuse, or any other reason, as judged by the investigator. 11. Previous randomisation of treatment in the present study or participation in a clinical study during the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess how PPI treated GERD-patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to continued pre-study PPI treatment. ;Secondary Objective: To assess productivity with regard to symptom severity and frequency by evaluation of the updated version of Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease (WPAI-GERD)questionnaire. To assess utility values with regard to symptom severity and frequency by evaluation of EQ-5D questionnaire. To describe which patients will benefit from a more efficient acid secretion inhibitor by evaluation of a Quality Assurance of GERD Treatment Questionnaire (Kvalitetsuppföljning av Refluxterapi, KURT). To evaluate Willingness To Pay (WTP) with regard to symptom relief by assessment of WTP questions. To assess safety by evaluation of Serious Adverse Events (SAE) and Discontinuations due to Adverse Events (DAE). ;Primary end point(s): The primary variable is the proportion of patients free from heartburn after 4 weeks treatment, defined as not more than 1 day with mild symptoms during the last week before last visit | — |
Countries
Sweden
Outcome results
None listed