Recruitment

Recruitment Status
Completed

Inclusion Criterias

either (a) having had a documented episode of postprandial hypoglycemia in the medical history
or either (b) demonstrating a hypoglycemia (<60mg/dl) or hematocrite increase of > 3% or a pulse increase of 10 bpm after an oral glucose tolerance test with 75 g of glucose.
Male or female patients aged between 18 and 80 years.
...
either (a) having had a documented episode of postprandial hypoglycemia in the medical history
or either (b) demonstrating a hypoglycemia (<60mg/dl) or hematocrite increase of > 3% or a pulse increase of 10 bpm after an oral glucose tolerance test with 75 g of glucose.
Male or female patients aged between 18 and 80 years.
Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication washout period
Patients with diagnosis of Dumping Syndrome:

Exclusion Criterias

Patients with the diagnosis of Diabetes Mellitus
History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
...
Patients with the diagnosis of Diabetes Mellitus
History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
Patients with the presence of active or suspected acute or chronic uncontrolled infection
Patients who have undergone major surgery/surgical therapy for any cause within 1 month
Patients who have a known hypersensitivity to somatostatin analogues.
Patients with important co-morbidity (cardiac, pulmonary, renal , hepatic diseases)
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception in addition to condoms. If oral contraception is used, the patient must have been practicing this method for at least three months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for 3 months afterwards.
Patients receiving anticoagulants that affect PT or PTT
Patients who have failed treatment with somatostatin analogues in the past (specifically patients who have been treated with octreotide s.c. for more than 2 days or with a long acting somatostatin analogue for more than 8 weeks).
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
Patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old).
Patients who have been treated with somatostatin analogues during the last 12 weeks before inclusion.
Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing

Summary

Conditions
Postoperative Dumping Syndrome
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

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...

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.

Inclusion Criterias

either (a) having had a documented episode of postprandial hypoglycemia in the medical history
or either (b) demonstrating a hypoglycemia (<60mg/dl) or hematocrite increase of > 3% or a pulse increase of 10 bpm after an oral glucose tolerance test with 75 g of glucose.
Male or female patients aged between 18 and 80 years.
...
either (a) having had a documented episode of postprandial hypoglycemia in the medical history
or either (b) demonstrating a hypoglycemia (<60mg/dl) or hematocrite increase of > 3% or a pulse increase of 10 bpm after an oral glucose tolerance test with 75 g of glucose.
Male or female patients aged between 18 and 80 years.
Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication washout period
Patients with diagnosis of Dumping Syndrome:

Exclusion Criterias

Patients with the diagnosis of Diabetes Mellitus
History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
...
Patients with the diagnosis of Diabetes Mellitus
History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
Patients with the presence of active or suspected acute or chronic uncontrolled infection
Patients who have undergone major surgery/surgical therapy for any cause within 1 month
Patients who have a known hypersensitivity to somatostatin analogues.
Patients with important co-morbidity (cardiac, pulmonary, renal , hepatic diseases)
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception in addition to condoms. If oral contraception is used, the patient must have been practicing this method for at least three months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for 3 months afterwards.
Patients receiving anticoagulants that affect PT or PTT
Patients who have failed treatment with somatostatin analogues in the past (specifically patients who have been treated with octreotide s.c. for more than 2 days or with a long acting somatostatin analogue for more than 8 weeks).
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
Patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old).
Patients who have been treated with somatostatin analogues during the last 12 weeks before inclusion.
Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing

Locations

Leuven, Vlaams-Brabant, 3000
Leuven, Vlaams-Brabant, 3000

Tracking Information

NCT #
NCT01895296
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jan Tack, M.D., Ph.D. Universitaire Ziekenhuizen Leuven
  • Jan Tack, M.D., Ph.D. Universitaire Ziekenhuizen Leuven