Sancuso® for Gastroparesis: An Open Label Study.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Gastroparesis

Clinical Trial Details

NCT number	NCT01989221
Study type	Interventional
Source	Temple University
Contact
Status	Completed
Phase	Phase 3
Start date	November 2012
Completion date	December 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.