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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Sancuso® in Patients With Nausea and/or Vomiting From Gastroparesis: An Open Label Study.|
- GCSI-DD nausea/vomiting symptom scores. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
- Total Gastrointestinal Cardinal Symptom Index [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo - Control
Active Comparator: Sancuso®
Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
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:
- Determine the treatment response of Sancuso® in gastroparetic patients with nausea and/or vomiting.
- Determine which specific symptoms of gastroparesis improve - nausea, vomiting, early satiety, abdominal distension, abdominal pain
- To determine symptomatic responses in both diabetic and idiopathic gastroparesis
- To determine the time course of symptom improvement (with Sancuso® for symptoms of gastroparesis;
The hypotheses to be tested include:
- Sancuso® improves symptoms of gastroparesis.
- Symptoms of nausea and vomiting improve to a greater degree than abdominal pain.
- The beneficial response of Sancuso® is seen in both diabetic and idiopathic gastroparesis.
- The symptom reduction occurs on days 3 after starting treatment and continues throughout the treatment course.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01989221
|Contact: Henry P Parkman, MD||(215) firstname.lastname@example.org|
|United States, Pennsylvania|
|Temple University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19140|
|Contact: Henry P. Parkman, MD 215-707-3431 email@example.com|
|Principal Investigator: Henry P. Parkman, MD|
|Principal Investigator:||Henry P Parkman, MD||Temple University Hospital|