Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome

Completed · Phase 2

Conditions studied: Dumping Syndrome

In brief

multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome

Key facts

Study ID

NCT01637272

Run by

Novartis Pharmaceuticals

People needed

43

Starts

2013-01-08

Expected to finish

2015-08-07

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Bariatric patients who had lap band.
• Patients with a current diagnosis of diabetes mellitus.
• Patients who had failed treatment with somatostatin analogues for dumping syndrome in the past.
• Patients who had been treated with somatostatin analogues in the past, must have had an appropriate interval between the last administration of somatostatin analogues treatment and the study drug as follows
• Octreotide sc for ≥ 72 hours
• Octreotide LAR for ≥ 56 days (8 weeks)
• Lanreotide Autogel for ≥ 98 days (14 weeks)
• Lanreotide SR ≥ 28 days (4 weeks)
• Patients who were already treated with pasireotide.
• Patients who had a known hypersensitivity to somatostatin analogues.
• Patients who were receiving anti-cancer therapy (chemotherapy and/or radiotherapy).
• Patients who had any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
• Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot). An HIV test was not required; however, previous medical history was reviewed.
• Non-malignant medical illnesses that were uncontrolled or whose control may have been jeopardized by the treatment with this study treatment.
• Life-threatening autoimmune and ischemic disorders.
• Patients with the presence of active or suspected acute or chronic uncontrolled infection.
• Inadequate end organ function as defined by:
• Inadequate bone marrow function:
• White blood cells (WBC) <2.5 x 109/L
• Absolute neutrophil count <1.5 x 109/L
• Platelets <100 x 109/L
• Hemoglobin <9 g/dL
• International normalized ratio (INR) ≥ 1.3
• Serum creatinine >2.0 mg/dL
• Alkaline phosphatase (ALP) >2.5 x upper limit of normal (ULN)

Where it is running

• Ximed Center for Weight Management Ximed Research — La Jolla, California, United States
• Stanford University Medical Center SC - SOM230X2203 — Stanford, California, United States
• Mayo Clinic - Rochester Mayo MN — Rochester, Minnesota, United States
• Montefiore Medical Center CLCZ696B2320 — The Bronx, New York, United States
• Texas Tech University Health Science Center — El Paso, Texas, United States
• Virginia Endocrinology Research SC — Chesapeake, Virginia, United States
• Novartis Investigative Site — Bruges, Belgium, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Pessac, France
• Novartis Investigative Site — Pierre-Bénite, France
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Utrecht, Netherlands, Netherlands
• Novartis Investigative Site — Groningen, Netherlands

Full record on ClinicalTrials.gov

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