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Sancuso® for Gastroparesis: An Open Label Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Henry P. Parkman, MD, Temple University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Sancuso® Phase 3

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo - Control
Active Comparator: Sancuso®
Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
Drug: Sancuso®
Drug: Placebo

Primary Outcome Measures :
  1. GCSI-DD nausea/vomiting symptom scores. [ Time Frame: Four weeks ]

Secondary Outcome Measures :
  1. Total Gastrointestinal Cardinal Symptom Index [ Time Frame: Four weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01989221

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Contact: Henry P Parkman, MD (215) 707-3431

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United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P. Parkman, MD    215-707-3431   
Principal Investigator: Henry P. Parkman, MD         
Sponsors and Collaborators
Temple University
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Principal Investigator: Henry P Parkman, MD Temple University Hospital

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Responsible Party: Henry P. Parkman, MD, Professor, Temple University Identifier: NCT01989221     History of Changes
Other Study ID Numbers: 21086
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action