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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
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

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)

Condition or disease Intervention/treatment Phase
Postoperative Dumping Syndrome Drug: Pasireotide Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Arm Intervention/treatment
Experimental: Pasireotide
pasireotide 300 microgram s.c. t.i.d.
Drug: Pasireotide
somatostatin analogue pasireotide
Other Name: SOM230

Placebo Comparator: Placebo
saline s.c. t.i.d.
Drug: Placebo
placebo s.c.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Effect on hypoglycemia [ Time Frame: 2 weeks ]
    • The secondary efficacy variables include the proportion of patients with reduced hypoglycemic events


Other Outcome Measures:
  1. Control of Hct rise [ Time Frame: 2 weeks ]
    Proportion of patients with hematocrit rise during OGTT

  2. Control of pulse rate rise [ Time Frame: 2 weeks ]
    Proportion of patients with pulse rate rise during OGTT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Belgium
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Jan Tack, M.D., Ph.D. Universitaire Ziekenhuizen Leuven

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Responsible Party: Prof Dr Jan Tack, Professor of Medicine, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01895296     History of Changes
Other Study ID Numbers: CSOM230BBE01T
2008-000700-84 ( EudraCT Number )
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013
Keywords provided by Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven:
dumping syndrome
OGTT
hypoglycemia
Additional relevant MeSH terms:
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Postgastrectomy Syndromes
Hormones, Hormone Substitutes, and Hormone Antagonists
Dumping Syndrome
Syndrome
Disease
Pathologic Processes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pasireotide
Hormones
Physiological Effects of Drugs