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

NCT01895296 | Completed Phase 2

• 2 other identifiers: CSOM230BBE01T2008-000700-84
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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)

Conditions

Postoperative Dumping Syndrome

Keywords

dumping syndrome; OGTT; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (1)

• Effect on hypoglycemia

  2 weeks

Other Outcomes (2)

• Control of Hct rise

  2 weeks

• Control of pulse rate rise

  2 weeks

Study Arms (2)

Pasireotide

EXPERIMENTAL

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

Drug: Pasireotide

Placebo

PLACEBO COMPARATOR

saline s.c. t.i.d.

Drug: Placebo

Interventions

Pasireotide DRUG

somatostatin analogue pasireotide

Also known as: SOM230

Pasireotide

Placebo DRUG

placebo s.c.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Dumping Syndrome; Hypoglycemia

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Postgastrectomy Syndromes; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jan Tack, M.D., Ph.D.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 10, 2013
• Study Start: September 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

BE (1)