Sancuso® for Gastroparesis: An Open Label Study.
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Sancuso®
Intervention type(s): Drug
Intervention description(s): Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
Intervention MeSH terms: Granisetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic