CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
granisetrondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02457195
NCT02457195Phase 2Completed

Preoperative Use of Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting (PONV) in Patients With History of Severe PONV - Open Label, Prospective, Pilot Study

Milton S. Hershey Medical Center·interventional·Posted May 29, 2015·Updated Dec 18, 2019

In Brief

A Phase 2 clinical trial evaluating granisetron for Postoperative Nausea and Vomiting. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The objective of the study is to evaluate the efficacy and safety of adding transdermal preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing surgical procedure under general anesthesia. The specific aims of the study include: 1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery 2. incidence and seriousness of the observed side effects 3. ability of patients to self-administer preoperatively and maintain the investigated patch during the perioperative period 4. level of satisfaction with the preoperative PONV prophylaxis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 29, 2015
Enrollment StartFeb 1, 2016
Primary CompletionFeb 19, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.1 years ago

Interventions

granisetrondrug

Application granisetron transdermal patch preoperatively