Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With D… (NCT01637272) | Clinical Trial Compass
CompletedPhase 2
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
United States43 participantsStarted 2013-01-08
Plain-language summary
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:.
* Male or female patients ≥ 18 years of age.
* Post-gastric or esophageal bypass surgery, matching one of the criteria below:
* Bariatric surgery: more than 6 months before signing the informed consent
* Esophageal cancer surgery: were disease free at study entry
* Gastric cancer surgery: were at stage 0 or I and were disease free at study entry
* Patient with a documented diagnosis of Dumping Syndrome defined as having:
* History of/or active symptoms associated with dumping syndrome (e.g. post-prandial tachycardia, bloating, diarrhea) and
* Documented history of hypoglycemia based on either:
* glucose \<50 mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis -or
* glucose value \<60 mg/dL or ≤ 3.3 mmol/L at 90, 120, 150 or 180 min during an OGTT
* Patients had at least one glucose level \<60 mg/dL (or ≤ 3.3 mmol/L) at 90, 120, 150 or 180 min during the 3-hour OGTT at screening.
* Patients with esophageal cancer with a negative computed tomography (CT) or Magnetic resonance imaging (MRI) scan (neck, thoracic, and upper abdominal) and albumin
≥ 3.5 g/dl at baseline.
* Patients with gastric cancer with a negative CT or MRI scan (total abdomen).
* Karnofsky Performance Status ≥ 60 (i.e. required occasional assistance, but was able to care for most of their personal needs)
* Patients who received other therapies for dumping syndrome (such as acarbose, gama guar, pectin) must have stopped all treatments and had a wash out period prior to signing …