Sancuso® for Gastroparesis: An Open Label Study.
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Sancuso®
Intervention description: Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
Intervention MeSH terms: Granisetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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