Sancuso® for Gastroparesis: An Open Label Study.
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | November 2012 |
| End Date: | July 2015 |
| Contact: | Henry P Parkman, MD |
| Email: | henry.parkman@temple.edu |
| Phone: | (215) 707-3431 |
Sancuso® in Patients With Nausea and/or Vomiting From 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.
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.
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.
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.
Inclusion Criteria:
- Age 18 to 65 years of age Diagnosed gastroparesis patients with symptoms of
gastroparesis for at least 3 months Symptoms of nausea and vomiting of at least
moderate severity using the GCSI Prior history of delayed gastric emptying as
determined by scintigraphy Gastroparesis from either diabetic or idiopathic
etiologies Symptoms of nausea and vomiting that have not responded adequately to
conventional antiemetic agents (Compazine®, Tigan®)
Exclusion Criteria:
- Post-surgical gastroparesis Prolonged QTc on EKG Prior intolerance to 5HT3
antagonists (ondansetron or granisetron) Known hypersensitivity to granisetron or to
any of the components of the patch Current treatment with ondansetron or granisetron.
Patients may stop these medications for one week to enter the study. Patients will
not be allowed to take ondansetron or oral granisetron during the study.
Use of ketoconazole, a medications with known drug-drug interactions with granisetron
Women known to be pregnant, as determined on enrollment by a urine pregnancy test Women of
childbearing potential who do not agree to use a medically approved form of contraception
Nursing mothers
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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