The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
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|ClinicalTrials.gov Identifier: NCT04071080|
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urine Sample Authenticity||Drug: fluorescein sodium Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase I, Randomized, Double-blind, Placebo-controlled Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples|
|Actual Study Start Date :||August 22, 2019|
|Actual Primary Completion Date :||November 28, 2019|
|Actual Study Completion Date :||November 28, 2019|
Experimental: 100mg Fluorescein disodium
100mg Fluorescein disodium will be mixed with 500mL of Gatorade and taken orally by the participant
Drug: fluorescein sodium
Fluorescein sodium in 500mL Gatorade
Other Name: Fluorescite
Placebo Comparator: Placebo
500mL of Gatorade taken orally by the participant
- Percentage of patients with detectable urine fluorescence using an ophtalmoscope equipped with a cobalt blue filter [ Time Frame: Up to 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071080
|Medicor Research Inc.|
|Sudbury, Ontario, Canada, P3A 1W8|