Clinical Trial: SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

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

Detailed Summary:

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
Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome: Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo. [ Time Frame: at week 11 and week 27 during the study ]

Early dumping starts immediately after a meal, within 1 hour (< 1 hour). Late dumping starts later than 1 hour after a meal (≥ 1 hour). Each item is scored from zero (not present) 1 (mild) , 2 (moderate) and 3 (severe). Early dumping symptoms : sweating, flushes, dizziness, palpitations, abdominal pain, diarrhea, bloating, nausea. Late dumping symptoms : sweating, palpitations, hunger, drowsiness to unconsciousness, shaking and aggression.

The change in dumping score will be assessed after 11 weeks and a second time after cross over at week 27.

Additionally, the overall improvement is assessed by asking "how do you feel compared with your situation before starting the study at week 11. The same question is asked at week 27. Additionally at week 27 the following question is asked " How do you feel compared with your situation 4 months ago ?" Scoring is done on a 7 point Likert scale.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in quality of life. [ Time Frame: week 0, 11, 16 and 27 ]
    To assess the effect of Somatuline 90 mg versus placebo on a standardized quality of life questionnaire (QOL SF-36).
  • The difference in number of participants with adverse events between somatuline 90 mg versus placebo [ Time Frame: at week 27 (end of the study) ]
    To assess the tolerability of Somatuline 90 mg versus placebo.


Original Secondary Outcome:

  • To assess the change in quality of life. [ Time Frame: week 0, 11, 16 and 27 ]
    To assess the effect of Somatuline 90 mg versus placebo on a standardized quality of life questionnaire (QOL SF-36).
  • The difference in number of participants with adverse events between somatuline 90 mg versus placebo [ Time Frame: at week 27 (end of the study) ]
    To assess the tolerability of Somatuline 90 mg versus placebo.


Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: July 19, 2013
Date Started: April 2008
Date Completion: December 2013
Last Updated: August 21, 2013
Last Verified: January 2013