EUCTR2013-004232-29-BE
Active, not recruiting
Phase 1
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)
Z Brussel0 sites15 target enrollmentDecember 4, 2013
Conditionspatients 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: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Z Brussel
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •Pregnancy or inadequate anticonception, breast feeding.
- •Negative impedancemetry.
Outcomes
Primary Outcomes
Not specified
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