Symptomatic versus Endoscopic approach for the Diagnosis and Initial treatment of Gastroesophageal Reflux Disease using GerdQ
- Conditions
- Diagnosis and initial treatment of gastroesofageal reflux disease.
- Registration Number
- EUCTR2008-006742-26-NO
- Lead Sponsor
- AstraZeneca AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 348
1.Provision of informed consent prior to any study specific procedures
2.Female or male aged 18 years or more
3.Symptoms suggestive of typical GERD (heartburn or acid regurgitation as predominant symptoms) referred to or followed up by gastroenterologist
4.Understand and complete the questionnaires.
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) yes
F.1.3.1 Number of subjects for this age range
1.Major health condition that precludes participation, as judged by the investigator
2.Alarm symptoms defined as unintentional weight loss, severe or progressive dysphagia, and upper GI bleeding
3.Use of more than 2 doses per week of PPI and H2RA, and use of more than one daily dose of antacids within 2 weeks prior to Visit 1
4.Endoscopic and/or pH-metry examination within 1 year prior to Visit 1
5.Previous upper GI surgery
6.Participation in any clinical study within the defined treatment period
7.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method