Sancuso® for Gastroparesis: An Open Label Study.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Temple University
Sponsor:
Information provided by (Responsible Party):
Henry P. Parkman, MD, Temple University
ClinicalTrials.gov Identifier:
NCT01989221
First received: November 14, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Gastroparesis
Drug: Sancuso®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sancuso® in Patients With Nausea and/or Vomiting From Gastroparesis: An Open Label Study.

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • GCSI-DD nausea/vomiting symptom scores. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Gastrointestinal Cardinal Symptom Index [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo - Control
Active Comparator: Sancuso®
Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
Drug: Sancuso®
Drug: Placebo

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989221

Contacts
Contact: Henry P Parkman, MD (215) 707-3431 henry.parkman@temple.edu

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P. Parkman, MD    215-707-3431    henry.parkman@temple.edu   
Principal Investigator: Henry P. Parkman, MD         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Henry P Parkman, MD Temple University Hospital
  More Information

No publications provided

Responsible Party: Henry P. Parkman, MD, Professor, Temple University
ClinicalTrials.gov Identifier: NCT01989221     History of Changes
Other Study ID Numbers: 21086
Study First Received: November 14, 2013
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014