CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Fentanyl pectindrug
Likely dose
Fentanyl pectin 100mcgfrom 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/NCT01756651
NCT01756651Phase 1Completed
CompareCT.gov

A Prospective Study Comparing the Efficacy and Safety of 100 mcg and 200 mcg of Intranasal Fentanyl Pectin Spray as an Analgesic in Adult Males Undergoing Outpatient Cystoscopic Procedures

Richard C Reznichek, MD·interventional·Posted Dec 27, 2012·Updated May 11, 2017

In Brief

A Phase 1 clinical trial evaluating Fentanyl pectin for Other Acute Pain and Pain Experienced During Cystoscopy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOther Acute Pain, Pain Experienced During Cystoscopy
CountriesUnited States
CollaboratorsDepomed

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 27, 2012
Enrollment StartFeb 1, 2013
Primary CompletionMay 10, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.5 years ago

Interventions

Fentanyl pectindrug

comparison of Intranasal fentanyl 100mcg vs 200 mcg.