Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome (CSOM230BBE01T)
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|ClinicalTrials.gov Identifier: NCT01895296|
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : July 10, 2013
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)
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Dumping Syndrome||Drug: Pasireotide Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
pasireotide 300 microgram s.c. t.i.d.
somatostatin analogue pasireotide
Other Name: SOM230
Placebo Comparator: Placebo
saline s.c. t.i.d.
- Primary efficacy endpoint: symptoms related to Dumping Syndrome Severity Score [ Time Frame: 2 weeks ]
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 ]• The secondary efficacy variables include the proportion of patients with reduced hypoglycemic events
- Control of Hct rise [ Time Frame: 2 weeks ]Proportion of patients with hematocrit rise during OGTT
- Control of pulse rate rise [ Time Frame: 2 weeks ]Proportion of patients with pulse rate rise during OGTT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895296
|University Hospitals Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Jan Tack, M.D., Ph.D.||Universitaire Ziekenhuizen Leuven|