Sancuso® for Gastroparesis: An Open Label Study.
|ClinicalTrials.gov Identifier: NCT01989221|
Recruitment Status : Unknown
Verified May 2015 by Henry P. Parkman, MD, Temple University.
Recruitment status was: Recruiting
First Posted : November 20, 2013
Last Update Posted : May 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Drug: Sancuso®||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sancuso® in Patients With Nausea and/or Vomiting From Gastroparesis: An Open Label Study.|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
Placebo Comparator: Placebo
Placebo - Control
Active Comparator: Sancuso®
Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
- GCSI-DD nausea/vomiting symptom scores. [ Time Frame: Four weeks ]
- Total Gastrointestinal Cardinal Symptom Index [ Time Frame: Four weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|