Treatment of the Dumping Syndrome With Lanreotide Autogel®

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00543179
First received: October 11, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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 Intervention Phase
Dumping Syndrome
Drug: Somatuline (Lanreotide Autogel®)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of the Dumping Syndrome With Lanreotide Autogel®

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ]

Study Start Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543179

Contacts
Contact: Serena Slavenburg, MD +31243617272 s.slavenburg@mdl.umcn.nl

Locations
Netherlands
UMC St. Radboud Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Serena Slavenburg, MD    +31243617272    s.slavenburg@mdl.umcn.nl   
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Jan BMJ Jansen, MD, PhD UMC. St. Radboud Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00543179     History of Changes
Other Study ID Numbers: 2007/064
Study First Received: October 11, 2007
Last Updated: October 11, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Dumping Syndrome
Postgastrectomy Syndromes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014