Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome (CSOM230BBE01T)
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 :
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during OGTT).
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during OGTT).
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as measured by the combined Dumping Syndrome score
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured by (a) early and (b) late phase dumping symptom score separately
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL SF-36)
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome|
- Primary efficacy endpoint: symptoms related to Dumping Syndrome Severity Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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
- Effect on hypoglycemia [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]• The secondary efficacy variables include the proportion of patients with reduced hypoglycemic events
- Control of Hct rise [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Proportion of patients with hematocrit rise during OGTT
- Control of pulse rate rise [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Proportion of patients with pulse rate rise during OGTT
|Study Start Date:||September 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
pasireotide 300 microgram s.c. t.i.d.
somatostatin analogue pasireotide
Other Name: SOM230
Placebo Comparator: Placebo
saline s.c. t.i.d.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01895296
|University Hospitals Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Jan Tack, M.D., Ph.D.||University Hospitals Leuven|