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Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome (CSOM230BBE01T)

Primary Purpose

Postoperative Dumping Syndrome

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Pasireotide
Placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Dumping Syndrome focused on measuring dumping syndrome, OGTT, hypoglycemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients aged between 18 and 80 years.
  • Patients with diagnosis of Dumping Syndrome:

  • Having symptoms of Dumping Syndrome (sum of combined Dumping Syndrome score ≥10) AND

    • 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.
  • 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

Exclusion Criteria:

  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month
  • Patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old).
  • 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 who have been treated with somatostatin analogues during the last 12 weeks before inclusion.
  • Patients who have a known hypersensitivity to somatostatin analogues.
  • Patients with the diagnosis of Diabetes Mellitus
  • Patients with important co-morbidity (cardiac, pulmonary, renal , hepatic diseases)
  • Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
  • Patients receiving anticoagulants that affect PT or PTT
  • 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.
  • 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 who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
  • 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 the presence of active or suspected acute or chronic uncontrolled infection
  • 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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pasireotide

Placebo

Arm Description

pasireotide 300 microgram s.c. t.i.d.

saline s.c. t.i.d.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect on hypoglycemia
• The secondary efficacy variables include the proportion of patients with reduced hypoglycemic events

Full Information

First Posted
July 1, 2013
Last Updated
July 4, 2013
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01895296
Brief Title
Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
Acronym
CSOM230BBE01T
Official Title
Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Dumping Syndrome
Keywords
dumping syndrome, OGTT, hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pasireotide
Arm Type
Experimental
Arm Description
pasireotide 300 microgram s.c. t.i.d.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
saline s.c. t.i.d.
Intervention Type
Drug
Intervention Name(s)
Pasireotide
Other Intervention Name(s)
SOM230
Intervention Description
somatostatin analogue pasireotide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo s.c.
Primary Outcome Measure Information:
Title
Primary efficacy endpoint: symptoms related to Dumping Syndrome Severity Score
Description
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
Secondary Outcome Measure Information:
Title
Effect on hypoglycemia
Description
• The secondary efficacy variables include the proportion of patients with reduced hypoglycemic events
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Control of Hct rise
Description
Proportion of patients with hematocrit rise during OGTT
Time Frame
2 weeks
Title
Control of pulse rate rise
Description
Proportion of patients with pulse rate rise during OGTT
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged between 18 and 80 years. Patients with diagnosis of Dumping Syndrome: Having symptoms of Dumping Syndrome (sum of combined Dumping Syndrome score ≥10) AND 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. 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 Exclusion Criteria: Patients who have undergone major surgery/surgical therapy for any cause within 1 month Patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old). 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 who have been treated with somatostatin analogues during the last 12 weeks before inclusion. Patients who have a known hypersensitivity to somatostatin analogues. Patients with the diagnosis of Diabetes Mellitus Patients with important co-morbidity (cardiac, pulmonary, renal , hepatic diseases) Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits) Patients receiving anticoagulants that affect PT or PTT 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. 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 who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing 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 the presence of active or suspected acute or chronic uncontrolled infection 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, M.D., Ph.D.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome

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