Phase 3 Completed N=14 Diagnostic

Sancuso® for Gastroparesis: An Open Label Study.

Gastroparesis

Source: ClinicalTrials.gov NCT01989221 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcomePrimary: GCSI-DD Total Composite Symptom Scores. — 1.89; 1.57; 1.34 score on a scale — p=<0.01

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY GCSI-DD Total Composite Symptom Scores.	1.89; 1.57; 1.34	<0.01 sig
SECONDARY Total Gastrointestinal Nausea and Vomiting Symptom Index	2.31; 1.69; 1.30	<0.01 sig

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01989221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.