Treatment of the Dumping Syndrome With Lanreotide Autogel®
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|ClinicalTrials.gov Identifier: NCT00543179|
Recruitment Status : Unknown
Verified October 2007 by Radboud University.
Recruitment status was: Recruiting
First Posted : October 12, 2007
Last Update Posted : October 12, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Dumping Syndrome||Drug: Somatuline (Lanreotide Autogel®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of the Dumping Syndrome With Lanreotide Autogel®|
|Study Start Date :||October 2007|
- Responses to the dumping provocation test. Effectiveness is defined as a heart rate increase of ≤ 10 beats/min and a negative breath-hydrogen test after glucose provocation test. [ Time Frame: baseline versus day 119 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543179
|Contact: Serena Slavenburg, MDfirstname.lastname@example.org|
|UMC St. Radboud Medical Center||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Contact: Serena Slavenburg, MD +31243617272 email@example.com|
|Principal Investigator:||Jan BMJ Jansen, MD, PhD||UMC. St. Radboud Medical Center|