SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
Condition: Dumping Syndrome
MeSH terms: Dumping Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the
      treatment of dumping syndrome.
    

Detailed description: 
      Dumping syndrome has characteristic alimentary and systemic manifestations. It is one of the
      most common postprandial syndromes observed after extensive gastric surgery. Dumping syndrome
      can be separated into an early and late phase depending on the occurrence of symptoms in
      relation to the time elapsed after a meal. The early phase occurs because of rapid delivery
      of large amounts of osmotic active solids and liquids into the duodenum. The late phase is
      caused by a rapid increase of the glycemia and insuline causing hypoglycemia when the
      nutrients are not available any more. Dumping syndrome is the direct result of alterations in
      the storage function of the stomach and/or the pyloric emptying mechanism.

      Incidence and severity of symptoms in dumping syndrome are related directly to the extent of
      gastric surgery. An estimated 25-50% of all patients who have undergone gastric surgery have
      some symptoms of dumping. Only 1-5% are reported to have severe disabling symptoms. Incidence
      of significant dumping has been reported to be 6-14% in patients after truncal vagotomy and
      drainage and from 14-20% in patients after partial gastrectomy. Incidence of dumping syndrome
      after proximal gastric vagotomy without any drainage procedure is less than 2%. In the
      pediatric population, dumping syndrome is described in children who have undergone Nissen
      fundoplication.

      Several treatments can be proposed to a patient with dumping. Initially a diet of several
      small meals with a low concentration of mono-and disaccharides is prescribed and the patient
      is asked to avoid liquids during a meal. Several medical treatments can be utilized as guar
      gum, to increase the viscosity and reduce gastric emptying; pectine, to avoid a late
      hypoglycemia; acarbose, to block the digestion of saccharides. Some of them have only a
      partial effect or important side effects.

      Surgical interventions like an interposition of an antiperistaltic jejunal segment will
      reduce the intestinal motility or a Roux-en-Y construction can be created. These surgical
      interventions are sometimes necessary but remain quite invasive and not always useful.

      Somatostatin analogues have been used with success in patients with dumping syndrome. They
      exert a strong inhibitory effect on the release of insulin and several gut-derived hormones.
      The effectiveness of analogues in controlling the symptoms of both early and late dumping has
      been demonstrated in several randomized control trials. Somatostatin analogues interfere with
      the pathophysiology of a dumping syndrome in several ways. Somatostatin analogues reduce the
      secretion of insulin and prevents the occurrence of a late hypoglycaemia; decrease the
      concentration of different hormones responsible for the vaso-dilatation and the activation of
      the renin-angiotensine system that is seen in the early faze of the dumping syndrome.
      Somatostatin has also an effect on gastric motility and transit time.

      One of the main problems is the high cost and daily subcutaneous administration of
      somatostatin analogues .

      Somatuline® Autogel is a slow-release formulation that requires only monthly injection and
      supply high-dose, stable serum levels of lanreotide. These agents provide improved patient
      compliance since they are administered on a monthly schedule.

      The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the
      treatment of dumping syndrome. This will be a 27 weeks double blinded placebo-controlled
      cross-over multicenter study assessing the effect of Somatuline 90 mg in patients with
      dumping syndrome.

      Reports on the therapeutic effectiveness of lanreotide in the management of dumping symptoms
      are scarce and based on small numbers of patients. Data on the effect of lanreotide in the
      treatment of dumping are missing. In this trial, all patients will be treated with Somatuline
      ® Autogel 90 mg. From a pharmacokinetic point of view, all patients will have reached steady
      state concentration of lanreotide after 12 weeks of treatment. After 12 weeks, a wash-out
      period of 4 weeks is inserted before patients will be crossed over to placebo or active
      treatment at week 16.
    

Intervention name(s): Lanreotide 90 mg slow release formulation; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lanreotide 90 mg slow release formulation is injected deep subcutaneously, every 4 weeks, three times and compared to placebo; Placebo for somatuline slow release 90 mg
Other intervention name(s): Somatulin autogel
Intervention MeSH terms: Lanreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative dumping; somatostatin analogues; somatulin; lanreotide; dumping syndrome