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NCT01989221 · ClinicalTrials.gov registry record · Phase 3

Sancuso® for Gastroparesis: An Open Label Study.

A Phase 3 study of Gastroparesis, sponsored by Temple University.

Completed
Registry status
Phase 3
Development phase
14
Enrollment target
1
Study location

NCT01989221 is a Phase 3 study of Gastroparesis that has completed, run by Temple University. The registered enrollment target is 14 participants, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01989221, a Phase 3 study of Gastroparesis, has completed, sponsored by Temple University.

COMPLETED
Registry status
Phase 3
Development phase
14 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Gastroparesis

Interventions

  • DRUG Sancuso®

Study Locations (1)

Pennsylvania

  • Temple University Hospital - Philadelphia

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-11
Est. Completion 2018-12
Phase Phase 3

Sponsor

Temple University

163 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01989221

The ClinicalTrials.gov registry entry for NCT01989221 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (95% lower). The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 1 intervention - of which Sancuso® is the first listed.

NCT01989221 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01989221 about?

NCT01989221 is a clinical study titled "Sancuso® for 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 patie...

What is the current status of trial NCT01989221?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2012-11. Estimated completion is 2018-12.

What conditions does trial NCT01989221 study?

This clinical trial studies the following conditions: Gastroparesis.

What interventions are being tested in trial NCT01989221?

The interventions under investigation include: Sancuso® (DRUG).

Who is sponsoring clinical trial NCT01989221?

This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01989221 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.