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.

Study Overview

• Status: Unknown
• Conditions: Dumping Syndrome
• Intervention / Treatment: Drug: Somatuline (Lanreotide Autogel®)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Serena Slavenburg, MD; Phone Number: +31243617272; Email: s.slavenburg@mdl.umcn.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Recruiting
      • UMC St. Radboud Medical Center
      • Contact: Serena Slavenburg, MD; Phone Number: +31243617272; Email: s.slavenburg@mdl.umcn.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	baseline versus day 119

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Jan BMJ Jansen, MD, PhD, UMC. St. Radboud Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: October 11, 2007
• First Submitted That Met QC Criteria: October 11, 2007
• First Posted (Estimate): October 12, 2007

Study Record Updates

• Last Update Posted (Estimate): October 12, 2007
• Last Update Submitted That Met QC Criteria: October 11, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Stomach Diseases; Postgastrectomy Syndromes; Syndrome; Dumping Syndrome; Antineoplastic Agents; Lanreotide
• Other Study ID Numbers: 2007/064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No