The effect of lanreotide on therapy resistant gastro-esophageal reflux

Phase 1

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: 14.1Level: LLTClassification code 10017924Term: Gastroesophageal refluxSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-004232-29-BE

Lead Sponsor: Z Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 15

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

Pregnancy or inadequate anticonception, breast feeding.
Negative impedancemetry.
Diabetes.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Clinical symptoms on day 14, 28, 56 and 84 compared to baseline

Secondary Outcome Measures

Name	Time	Method
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