Sancuso® for Gastroparesis: An Open Label Study.
Sancuso® for Gastroparesis: An Open Label Study.
The aim of this study is to determine the efficacy of Sancuso® (granisetron transdermal
 system) 3.1 mg/24 hours in improving symptoms of nausea and vomiting in patients with
 gastroparesis. This will be a prospective open-label study using Sancuso® to treat symptoms
 of nausea and/or vomiting in patients diagnosed with gastroparesis. Symptomatic patients with
 diabetic or idiopathic gastroparesis with nausea and/or vomiting will be enrolled. The
 Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) will be used to capture the
 severity of symptoms, including nausea and vomiting, at baseline for one week. Patients will
 then be treated with Sancuso®. Patients will continue to fill out the GCSI-DD on a daily
 basis while undergoing treatment with Sancuso® for two weeks. To determine if Sancuso®
 treatment helps improve symptoms of nausea and vomiting, the symptoms at baseline will be
 compared to symptoms after the first week and the second week of treatment. Thirty patients
 diagnosed with gastroparesis (approximately 15 with diabetic and 15 with idiopathic
 gastroparesis) will be treated on an open label basis with Sancuso®. The goal of this study
 is to demonstrate the efficacy of Sancuso® in treating nausea and/or vomiting in
 gastroparesis patients. Safety information will also be collected regarding any adverse
 effects. If the results are encouraging, as we expect them to be based on personal
 experience, a larger double blind study would be appropriate.
Objectives The aim of this study is determine the efficacy of Sancuso® in improving symptoms
 of nausea and vomiting in patients with gastroparesis.

 The specific objectives of this study are to determine:

 1. Determine the treatment response of Sancuso® in gastroparetic patients with nausea
 and/or vomiting.

 2. Determine which specific symptoms of gastroparesis improve - nausea, vomiting, early
 satiety, abdominal distension, abdominal pain

 3. To determine symptomatic responses in both diabetic and idiopathic gastroparesis

 4. To determine the time course of symptom improvement (with Sancuso® for symptoms of
 gastroparesis;

 The hypotheses to be tested include:

 1. Sancuso® improves symptoms of gastroparesis.

 2. Symptoms of nausea and vomiting improve to a greater degree than abdominal pain.

 3. The beneficial response of Sancuso® is seen in both diabetic and idiopathic
 gastroparesis.

 4. The symptom reduction occurs on days 3 after starting treatment and continues throughout
 the treatment course.
Inclusion Criteria:

 -  Age 18 to 65 years of age Diagnosed gastroparesis patients with symptoms of
 gastroparesis for at least 3 months Symptoms of nausea and vomiting of at least
 moderate severity using the GCSI Prior history of delayed gastric emptying as
 determined by scintigraphy Gastroparesis from either diabetic or idiopathic etiologies
 Symptoms of nausea and vomiting that have not responded adequately to conventional
 antiemetic agents (Compazine®, Tigan®)

 Exclusion Criteria:

 -  Post-surgical gastroparesis Prolonged QTc on EKG Prior intolerance to 5HT3 antagonists
 (ondansetron or granisetron) Known hypersensitivity to granisetron or to any of the
 components of the patch Current treatment with ondansetron or granisetron. Patients
 may stop these medications for one week to enter the study. Patients will not be
 allowed to take ondansetron or oral granisetron during the study.

 Use of ketoconazole, a medications with known drug-drug interactions with granisetron Women
 known to be pregnant, as determined on enrollment by a urine pregnancy test Women of
 childbearing potential who do not agree to use a medically approved form of contraception
 Nursing mothers