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Demand-oriented therapy with Gaviscon dual as add-on therapy for patients with chronical GERD and insuffcient PPI effect

Demand-oriented therapy with Gaviscon dual as add-on therapy for patients with chronical GERD and insuffcient PPI effect - LOPA III

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00010473
Enrollment
300
Registered
2016-05-23
Start date
2016-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K21.9 R12

Interventions

Group 1: During the observation timeframe of 14 days, patients should take the given Gaviscon sachets (as described in the package leaflet). Patients are asked to document their daily intake. The pret

Sponsors

Diakonie-Klinikum Jung-Stilling-Krankenhaus
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patient suffering from GERD (gastroesophageal reflux diseas) (>1 year) - Permanent on PPI (Proton Pump Inhibitors) therapy. - Symptoms in the previous week for at least 2 days ( heartburn, regurgitation) - Dissatisfaction of the current therapy (score 1 or 2 in a scale from 1 (very dissatisfied) up to 5 (very satisfied)

Exclusion criteria

Exclusion criteria: - Patient, who do not comply with the inclusion criteria - Patients under the age of 18 year. - Patients who take antacid or other reflux medication beside the PPI standard therapy - Hypersensitivity against the active ingredient or one of the other components - Patients with hypercalcemia, nephrocalcinosis and repetitive calcium containing kidney stones - Patients with impaired renal function/ serious renal insufficiency - Patients with hypophosphatemia - Missing consent form

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the satisfaction after 2 week (final visit) 2 adjusted to the inclusion visit on Day 0.

Secondary

MeasureTime frame
Documentation of the disease parameter including: - Symptoms in week 2 - Satisfaction of the patient with the therapy (PPI+Gaviscon dual) - Assessment of the therapy: a) by the patient b) by the investigator

Countries

Germany

Contacts

Public ContactJoachim Labenz

Diakonie-Klinikum Jung-Stilling-Krankenhaus

Joachim.Labenz@diakonie-sw.de0271-3334569

Outcome results

None listed

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