NCT04071080

The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples

A Phase I, Randomized, Double-blind, Placebo-controlled Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: UpTru Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no drug) mixed in GatoradeTM. Participants will then provide a urine sample after 10, 15, 20 or 30 minutes to see if the investigator can detect fluorescein fluorescence (light) in the urine.

Detailed description

Every year, millions of dollars are spent on urine drug testing. Urine samples are generally provided in an unwitnessed fashion. Only a small percentage of samples involve direct observation of urination. The authenticity of the provided sample greatly affects its clinical utility and/or the validity of the test results. Direct observation of urination can be unpleasant and humiliating for people. For the institution, there are increased costs (for example, staff, insurance) and risks regarding impropriety when direct observation is utilized. Participants are being asked to take part in a research study of an approved drug called FluoresciteTM. FluoresciteTM is an intravenous drug (administered into a vein) that has been approved by Health Canada. The active ingredient in FluoresciteTM is fluorescein disodium (10% fluorescein disodium in sterile water). Fluorescein disodium has been used medically for over fifty years. It is a fluorophore (emits light, similar to a yellow glowstick) that is most commonly used in ophthalmology (the study and treatment of disorders and diseases of the eye). It is currently used in angiography (to view blood vessels), or topically for staining the eye's cornea. FluoresciteTM or fluorescein disodium has not been approved by Health Canada for oral administration. During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no drug) mixed in GatoradeTM. The Investigator will then ask the participant to provide a urine sample after 10, 15, 20 or 30 minutes to see if he can detect fluorescence (light) in the urine. The purpose of this study is to: * Develop a new standardized protocol for urine sampling that will increase sample authenticity and make the situation between the patient/physician more pleasant. * To evaluate the safety and tolerability of orally ingested fluorescein disodium.

Conditions

• Urine Sample Authenticity

Interventions

Type	Name	Description
DRUG	fluorescein sodium	Fluorescein sodium in 500mL Gatorade
DRUG	Placebo	500mL Gatorade

Timeline

• Start date: 2019-08-22
• Primary completion: 2019-11-28
• Completion: 2019-11-28
• First posted: 2019-08-28
• Last updated: 2020-01-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study