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Trial record 5 of 7 for:    "Postgastrectomy Syndrome" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

Treatment of the Dumping Syndrome With Lanreotide Autogel®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Radboud University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of the Dumping Syndrome With Lanreotide Autogel®
Study Start Date : October 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with typical early dumping symptoms after gastric surgery are selected on the basis of the clinical diagnostic index devised by Sigstad. In addition their dumping score after an oral glucose challenge (dumping provocation test) is positive (1,2);
  • Patients with late dumping are selected on the basis of a history suggestive of postprandial hypoglycaemia, a plasma glucose of less than 3.0 mm/l at least 60 min after ingestion of 50 g glucose/ m² body surface and hypoglycaemic symptoms at least 60 min after the oral glucose load;
  • Patients will be on long term octreotide LAR therapy;
  • Over 18 years of age;
  • Written informed consent

Exclusion Criteria:

  • patients with disorders of the endocrine system, patients with severe kidney, liver or cardiovascular disease;
  • Current or planned pregnancy or lactation;
  • Gastrointestinal surgery one year prior to inclusion;
  • Other gastrointestinal diseases that might influence symptoms of the dumping syndrome.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00543179

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Contact: Serena Slavenburg, MD +31243617272

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UMC St. Radboud Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Serena Slavenburg, MD    +31243617272   
Sponsors and Collaborators
Radboud University
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Principal Investigator: Jan BMJ Jansen, MD, PhD UMC. St. Radboud Medical Center

Layout table for additonal information Identifier: NCT00543179     History of Changes
Other Study ID Numbers: 2007/064
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: October 12, 2007
Last Verified: October 2007
Additional relevant MeSH terms:
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Postgastrectomy Syndromes
Hormones, Hormone Substitutes, and Hormone Antagonists
Dumping Syndrome
Pathologic Processes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Antineoplastic Agents
Physiological Effects of Drugs