- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01989221
Sancuso® for Gastroparesis: An Open Label Study.
Sancuso® in Patients With Nausea and/or Vomiting From Gastroparesis: An Open Label Study.
Study Overview
Detailed 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:
- 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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Placebo followed by Sancuso
Placebo at baseline for one week followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours for two weeks
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Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GCSI-DD Total Composite Symptom Scores.
Time Frame: Three weeks
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The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and two weeks of treatment with GTS.
The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms.
Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day.
A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.
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Three weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Gastrointestinal Nausea and Vomiting Symptom Index
Time Frame: Three weeks
|
The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and at two weeks of treatment with GTS.
The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms.
Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day.
A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.
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Three weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neurologic Manifestations
- Gastrointestinal Diseases
- Stomach Diseases
- Paralysis
- Gastroparesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Antagonists
- Granisetron
Other Study ID Numbers
- 21086
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroparesis
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Johns Hopkins UniversityCompletedDiabetic Gastroparesis | Idiopathic Gastroparesis | Gastroparesis PostoperativeUnited States
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Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
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Vanda PharmaceuticalsRecruitingGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
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Neurogastrx, Inc.CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
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Texas Tech University Health Sciences Center, El...CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
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TakedaCompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
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Millennium Pharmaceuticals, Inc.CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States, Belgium, Japan, Poland
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Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrolling by invitationFunctional Dyspepsia | Diabetics Without Symptoms of Gastroparesis | Diabetic Gastroparesis | Idiopathic Gastroparesis | Total or Partial Gastrectomy | Chronic NauseaUnited States
-
University of Erlangen-Nürnberg Medical SchoolNot yet recruiting
Clinical Trials on Sancuso®
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Prostrakan PharmaceuticalsCompleted
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Kyowa Kirin, Inc.PPDCompletedHealthy VolunteersUnited States
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Prostrakan PharmaceuticalsCompleted
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Prostrakan PharmaceuticalsCompletedPharmacokineticsUnited Kingdom
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Tianjin Medical University Cancer Institute and...RecruitingChemotherapy-induced Nausea and VomitingChina
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Indiana UniversityKyowa Kirin, Inc.Withdrawn
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LG Life SciencesUnknownChemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)Korea, Republic of
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Kyowa Kirin Pharmaceutical Development LtdWithdrawnChemotherapy Induced Nausea and Vomiting
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Milton S. Hershey Medical CenterCompletedPostoperative Nausea and VomitingUnited States
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Kyowa Kirin Pharmaceutical Development LtdWithdrawnChemotherapy Induced Nausea and Vomiting