A Phase 2 interventional study of Pasireotide and Placebo in Postoperative Dumping Syndrome, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 2, Interventional, and Treatment
Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this trial is to evaluate :
This will be a single centre, randomized, double-blind, controlled cross-over study during 35 days.
After a 4 weeks screening period, patients who fulfill the entrance criteria will be randomly assigned on a 1:1 basis to either the pasireotide treatment arm or to the placebo treatment arm. They will be treated with pasireotide sc or placebo sc for 2 weeks. After 2 weeks, patients will be switched to the other treatment arm after a 7 days wash out period. This phase is double-blind: both the patient and investigator will be blinded to treatment assignment.
Having symptoms of Dumping Syndrome (sum of combined Dumping Syndrome score ≥10) AND
Exclusion Criteria:
pasireotide 300 microgram s.c. t.i.d.
Drug: Pasireotide
saline s.c. t.i.d.
Drug: Placebo
somatostatin analogue pasireotide
Also known as: SOM230
placebo s.c.
Primary efficacy endpoint: symptoms related to Dumping Syndrome Severity Score
The dumping score is the sum of the early and late dumping symptoms. Early dumping starts immediately after a meal, within 1 hour (\< 1 hour). Late dumping starts later than 1 hour after a meal (≥ 1 hour). In case a symptom starts immediately after a meal and lasts longer than 1 hour, the score for early AND late dumping should be ticked. Dumping Score None Mild Moderate Severe Early Dumping 0 1 2 3 Sweating 0 1 2 3 Flushes 0 1 2 3 Dizziness 0 1 2 3 Palpitations 0 1 2 3 Abdominal pain 0 1 2 3 Diarrhea 0 1 2 3 Bloating 0 1 2 3 Nausea 0 1 2 3 None Mild Moderate Severe Late Dumping 0 1 2 3 Sweating 0 1 2 3 Palpitations 0 1 2 3 Hunger 0 1 2 3 Drowsiness to unconsciousness 0 1 2 3 Trembling 0 1 2 3 Irritability 0 1 2 3
Time frame: 2 weeks
Effect on hypoglycemia
• The secondary efficacy variables include the proportion of patients with reduced hypoglycemic events
Time frame: 2 weeks
Control of Hct rise
Proportion of patients with hematocrit rise during OGTT
Time frame: 2 weeks
Control of pulse rate rise
Proportion of patients with pulse rate rise during OGTT
Time frame: 2 weeks
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven