Randomized controlled clinical trial to evaluate the efficacy of alginates in washout of proton pump inhibitor therapy with consideration of compliance and symptom burden in patients with gastroesophageal reflux disease (GERD).

Phase 1

Conditions: Randomized controlled clinical trial to evaluate the efficacy of alginates in washout of proton pump inhibitor therapy with consideration of compliance and symptom burden in patients with gastroesophageal reflux disease (GERD).
MedDRA version: 20.0Level: LLTClassification code 10066874Term: Gastroesophageal reflux diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2022-003716-91-DE

Lead Sponsor: Centrum Gastroenterologie Bethanien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

•Patients of either sex aged = 18 years.
•Outpatients with ongoing PPI therapy (due to GERD) whose ongoing PPI intake is to be discontinued (e.g., prior to a planned diagnostic procedure).
•Signed consent to participate and to the collection and pseudonymized sharing of personal data.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Uncooperative patients
- Presence of red flag symptoms (dysphagia, anemia, weight loss in the past 3 months, recurrent bleeding, or recurrent vomiting)
- Presence of known Barrett's esophagus
•History of surgery to the esophagus or stomach
•Hypersensitivity to sodium alginate or potassium bicarbonate
•Allergy to the sweetener saccharin (E954)
•Allergy to spices, such as anise, mugwort, dill, fennel, carrot, coriander, cumin, paprika, parsley, celery and tomato
•Existing alcohol abuse or abuse of medications or drugs.
•Patients incapable of giving consent
•Patients who do not have sufficient command of the German language (consent form)
•Patients who are in a dependent relationship with the sponsor, investigator, other study personnel or the study center

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •Evaluation of the efficacy of GAVISCON® Advance compared to standard therapy upon PPI discontinuation. ;Secondary Objective: •Assessment of tolerability and safety of GAVISCON® Advance compared to standard therapy when discontinuing PPI. <br>•Assessment of compliance and symptom burden when using GAVISCON® Advance compared to standard therapy under the specific conditions of discontinuation of PPI therapy.;Primary end point(s): Modification of the sum score on efficacy to 16 items of the GERD-HRQL. The individual items are each rated on a 6-point scale (from 0 = no symptoms to 5 = severely impairing).;Timepoint(s) of evaluation of this end point: Comparison of the sum score on efficacy to 16 items of the GERD-HRQL. The individual items are each rated on a 6-point scale (from 0 = no symptoms to 5 = severely impairing).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Physician's judgment regarding tolerability. Further secondary objective parameters are efficacy and tolerability, which the patient assesses by means of a diary.<br>•Change in concomitant medication compared between groups (dose change / medication discontinued / new concomitant medication).<br>•Change of concomitant measures/interventions regarding GERD therapy tested (concomitant measure discontinued or new concomitant measure).;Timepoint(s) of evaluation of this end point: •Physician's judgment regarding tolerability. Further secondary objective parameters are efficacy and tolerability, which the patient assesses by means of a diary.<br>•Change in concomitant medication compared between groups (dose change / medication discontinued / new concomitant medication).<br>•Change of concomitant measures/interventions regarding GERD therapy tested (concomitant measure discontinued or new concomitant measure).