A Phase 4 interventional study of Somatuline (Lanreotide Autogel®) in Dumping Syndrome, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-12.
Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Treatment
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.
20 studies on the registry are indexed under Dumping Syndrome; 3 are open to participants now.
Browse Dumping Syndrome studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lanreotide Long-Acting Aqueous Gel
Radboud University Medical Center →