Dumping Syndrome Clinical Trial
Official title:
Treatment of the Dumping Syndrome With Lanreotide Autogel®
Background Somatostatin and octreotide LAR (long-acting analogue) exert a number of
inhibitory effects: on gut hormones, but also on gastro-intestinal secretion and motility.
Somatostatin analogues are effective in preventing symptoms and signs of both early and late
dumping as demonstrated previously. However, octreotide LAR causes gastrointestinal side
effects and the injection solution is difficult to prepare. Recently, a new somatostatin
analogue with a prolonged release formulation, Lanreotide autogel (L-autogel), has become
available. It is a viscous aqueous gel, composed solely of water and lanreotide. Deep
subcutaneous administration may lead to increased treatment acceptance compared with
intramuscular depot preparations. It is more easy to prepare and is though to cause less
local side effects and technical problems than octreotide LAR. Recent studies have been done
to measure the efficacy and safety of L-autogel in acromegalic treated previously with
octreotide LAR. These studies showed that L-autogel is effective and well-tolerated in these
patients, with equivalent or better disease control and less gastrointestinal adverse
events. Until now, there is no data available on the effectivety of L-autogel in patients
with a dumping syndrome. Therefore, this study aims to establish the effectiveness and
tolerability of L-autogel in patients with a dumping syndrome, previously treated with
octreotide LAR.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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