Sancuso® for Gastroparesis: An Open Label Study.
|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|