Symptomatic versus Endoscopic approach for the Diagnosis and Initial treatment of Gastroesophageal Reflux Disease using GerdQ

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006742-26-NO

Enrollment

348

Registered

2008-12-12

Start date

2009-01-08

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis and initial treatment of gastroesofageal reflux disease.

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: A statistical analysis comparing the impact of treatment in subjects using GerdQ (new structured pathway) versus the impact of treatment in subjects following current local practice (ordinary clinical pathway).;Secondary Objective: An evaluation of cost-effectiveness between the two pathways assessing the direct and indirect costs during study period. An evaluation of health status between the two pathways based on the EQ-5D measure. A summarisation of subjects with a verified upper GI organ damage encountered during the study period in both pathways. ;Primary end point(s): Disease control and symptom relief in the final assessment using GerdQ.	—

Measure

Time frame

Main Objective: A statistical analysis comparing the impact of treatment in subjects using GerdQ (new structured pathway) versus the impact of treatment in subjects following current local practice (ordinary clinical pathway).;Secondary Objective: An evaluation of cost-effectiveness between the two pathways assessing the direct and indirect costs during study period. An evaluation of health status between the two pathways based on the EQ-5D measure. A summarisation of subjects with a verified upper GI organ damage encountered during the study period in both pathways. ;Primary end point(s): Disease control and symptom relief in the final assessment using GerdQ.

—

Countries

Italy, Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026