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Pasireotide for High-output Enterostomy
NCT02713776Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2016
- Primary completion
- Jan 2021
- Countries
- 1
- Sponsor
- Hospices Civils de Lyon
- Modality
- Peptides, Small Molecules
- Drugs
- pasireotide LAR
- Conditions
- High output stoma (HOS)
01
Overview
Phase 2, randomised, double-blind trial in High output stoma (HOS) comparing Pasireotide with Placebo (2 arms). Primary endpoint: Reduction of high-output effluent volume at 72 hours. Started Dec 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Pasireotide
Pasireotide 0.9 mg SC bid for 3 days + Pasireotide LAR 60mg IM on Day 4
Placebo
Placebo SC bid for 3 days + Placebo IM on Day 4
03
Who it enrols
Adult patients with high-output enterostomy (>1000 ml/24h) following recent intestinal surgery, refractory to standard medical treatment (fluid restriction, loperamide, codeine).
04
Endpoints
Primary
Reduction of high-output effluent volume
Secondary
Success rate of treatment
Decrease in the length of hospitalization
Incidence of premature closure of stoma due to high-output
Economic impact of pasireotide
Incidence of Treatment-Emergent Adverse Events
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