Sancuso® for Gastroparesis: An Open Label Study.
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|