Treatment of the Dumping Syndrome With Lanreotide Autogel®

NCTNCT00543179Other id2007/064

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: Not stated
Sponsor: Radboud University Medical Center · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Netherlands
Start: Oct 2007
Primary completion: Not stated
Completion: Not stated
First posted: 12 Oct 2007 (estimated)
Last update posted: 12 Oct 2007 (estimated)
Conditions: Dumping Syndrome

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008

Ph 4
Treatment of the Dumping Syndrome With Lanreotide Autogel®
NCT00543179
Start Oct 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Somatuline (Lanreotide Autogel®)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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