CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
SOM230drug
Likely dose
SOM230 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01637272
NCT01637272Phase 2Completed
CompareCT.gov

A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome

Novartis Pharmaceuticals·interventional·Posted Jul 11, 2012·Updated May 10, 2017

In Brief

A Phase 2 clinical trial evaluating SOM230 for Dumping Syndrome. Completed, enrolled 43 participants across 17 sites in 5 countries.

Detailed Summary

multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDumping Syndrome
CountriesBelgium, France, Germany, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2012
Enrollment StartJan 8, 2013
Primary CompletionAug 7, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.0 years ago

Interventions

SOM230drug

Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg