CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 84 enrolled
Drug / intervention
Fentanyl Nasal Spray +2 moredrug
Likely dose
Fentanyl Nasal Spray 100 mcgfrom 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/NCT02459964
NCT02459964Phase 4Completed
CompareCT.gov

A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting

M.D. Anderson Cancer Center·interventional·Posted Jun 2, 2015·Updated Jun 16, 2021

In Brief

A Phase 4 clinical trial evaluating Fentanyl Nasal Spray, Hydromorphone Hydrochloride, and 1 other intervention for Advanced Cancers and Pain. Completed, enrolled 84 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to compare fentanyl nasal spray with a standard drug given by vein (hydromorphone hydrochloride) to help reduce pain related to cancer in patients coming to the emergency department.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancers, Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartSep 14, 2015
Primary CompletionJun 21, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.1 years ago

Interventions

Fentanyl Nasal Spraydrug

Fentanyl nasal spray 100 mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h)

Hydromorphone Hydrochloridedrug

Hydromorphone hydrochloride 1.5 mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).

Phone Callbehavioral

Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study. The phone call should last about 5 minutes.