The effect of lanreotide on therapy resistant gastro-esophageal reflux

A phase II proof of concept study to evalute the efficacy and safety of deep subcutaneous lanreotide Autogel 120 mg / 28 days on symptoms and healing of the esophageal and gastric mucosa in patients with gastro esophageal reflux resitant to standard therapy (combination of proton pump inhibitors and H2 antagonists)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004232-29-BE

Enrollment

Registered

2013-12-04

Start date

2014-01-02

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

patients with persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg pantoprazole before breakfast and dinner and 300 mg of H2 blocker ranitidine at bedtime AND continuing pathological reflux proven on impedancemetry. MedDRA version: 14.1 Level: LLT Classification code 10017924 Term: Gastroesophageal reflux System Organ Class: 100000004856

Interventions

Trade Name: Somatuline Autogel Injectable 120 mg Product Name: lanreotide autogel 120 mg Product Code: H01CB03 Pharmaceutical Form: Gel for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg pantoprazole before breakfast and dinner and 300 mg of H2 blocker ranitidine at bedtime AND continuing pathological reflux proven on impedancemetry. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Pregnancy or inadequate anticonception, breast feeding. Negative impedancemetry. Diabetes.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of lanreotide autgogel 120 mg on symptoms and endoscopic lesions in patients with a endoscopic reflux esophagitis that cannot be cured with classic therapy.;Secondary Objective: To evaluate the safety of lanreotide autgogel 120 mg in patients with a endoscopic reflux esophagitis that cannot be cured with classic therapy.;Primary end point(s): Improvement of reflux measured by impedancemetry and consequently improvement of lesions on endoscopy compared to baseline;Timepoint(s) of evaluation of this end point: Impedancemetery and endoscopy on day 84 compared to baseline Clinical symptoms on day 14, 28, 56 and 84 compared to baseline	—

Measure

Time frame

Main Objective: To evaluate the efficacy of lanreotide autgogel 120 mg on symptoms and endoscopic lesions in patients with a endoscopic reflux esophagitis that cannot be cured with classic therapy.;Secondary Objective: To evaluate the safety of lanreotide autgogel 120 mg in patients with a endoscopic reflux esophagitis that cannot be cured with classic therapy.;Primary end point(s): Improvement of reflux measured by impedancemetry and consequently improvement of lesions on endoscopy compared to baseline;Timepoint(s) of evaluation of this end point: Impedancemetery and endoscopy on day 84 compared to baseline Clinical symptoms on day 14, 28, 56 and 84 compared to baseline

—

Secondary

Measure	Time frame
Secondary end point(s): adverse events and serious adverse events on every time point in the study ;Timepoint(s) of evaluation of this end point: day 84	—

Countries

Belgium

Contacts

Public ContactStudy Nurse : Rita Vertommen

UZ Brussel

rita.vertommen@uzbrussel.be

Outcome results

None listed

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