Urine Sample AuthenticityPhase 1NCT04071080
The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
A Phase 1 study testing fluorescein sodium in people with Urine Sample Authenticity, run by UpTru Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Urine Sample Authenticity
- What is being tested?
- fluorescein sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2019to 28 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to comply with visits and study procedures.
- Healthy males and females between the age of 18 and 55.
- Female subjects are eligible to participate if they are not pregnant, breastfeeding and at least one of the following conditions apply:
- Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (based on the investigator's judgment) for 28 days before/after study drug administration.
- Is not of WOCBP (Postmenopausal and/or surgically sterile)
- Male subjects must use effective birth control methods and must not donate sperm until 2 weeks after treatment.
Who cannot join
- Staff members involved in the conduct of the study or their family members or site staff members supervised by the investigator. Subjects who are UPTru or Medicor employees, including their family members, directly involved in the conduct of the study are also not eligible to participate.
- Participants involved in any other study using an investigational product within 30 days or 5 half-lives (if known) prior to screening.
- Participants with any history of the following conditions:
- Known history of allergy (such as food or drug-induced urticaria, asthma, eczema or allergic rhinitis) or known allergy to fluorescein disodium or any component of FluoresciteTM or GatoradeTM.
- Jaundice, bronchial asthma, cirrhosis, uncontrolled diabetes (HbA1c ≥ 7.0), renal failure (calculated creatinine clearance of < 35 mL/min), cancer, HIV or hepatitis B/C.
- Participants with a life expectancy of fewer than 5 years.
- In the opinion of the investigator, any clinically significant abnormal ECG, vitals or laboratory result during screening that could put the participant at risk or affect the results of the study.
- Any concomitant medication that could potentially interact with the study drug or affect the results of the study (based on the investigator's opinion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
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.
Read the 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
- Being tested
- fluorescein sodium, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescein sodiumDrug
Also called Fluorescite
Fluorescein sodium in 500mL Gatorade
PlaceboDrug
500mL Gatorade
| Study group | Role | What they receive |
|---|---|---|
| 100mg Fluorescein disodium | Experimental | 100mg Fluorescein disodium will be mixed with 500mL of Gatorade and taken orally by the participant Receives: Drug: fluorescein sodium |
| Placebo | Placebo comparator | 500mL of Gatorade taken orally by the participant Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with detectable urine fluorescence using an ophtalmoscope equipped with a cobalt blue filter
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start22 Aug 2019
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Sample AuthenticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UpTru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicor Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071080
- Sponsor's protocol ID
- PH1.20180001
- Status last verified
- Jan 2020
- First submitted
- 22 Aug 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
- ClinicalTrials.gov ID
- NCT04071080
- Acronym / sponsor ID
- PH1.20180001
- Conditions
- Urine Sample Authenticity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UpTru Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medicor Research Inc.
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100mg Fluorescein disodium | Experimental | Drug: fluorescein sodium100mg Fluorescein disodium will be mixed with 500mL of Gatorade and taken orally by the participant |
| Placebo | Placebo comparator | Drug: Placebo500mL of Gatorade taken orally by the participant |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to comply with visits and study procedures.
- Healthy males and females between the age of 18 and 55.
- Female subjects are eligible to participate if they are not pregnant, breastfeeding and at least one of the following conditions apply:
- Male subjects must use effective birth control methods and must not donate sperm until 2 weeks after treatment.
Key exclusion criteria (8 listed)
- Staff members involved in the conduct of the study or their family members or site staff members supervised by the investigator. Subjects who are UPTru or Medicor employees, including their family members, directly involved in the conduct of the study are also not eligible to participate.
- Participants involved in any other study using an investigational product within 30 days or 5 half-lives (if known) prior to screening.
- Participants with any history of the following conditions:
- Participants with a life expectancy of fewer than 5 years.
- In the opinion of the investigator, any clinically significant abnormal ECG, vitals or laboratory result during screening that could put the participant at risk or affect the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorescein sodiumAlso: FluoresciteFluorescein sodium in 500mL Gatorade | Drug | 100mg Fluorescein disodium |
| Placebo500mL Gatorade | Drug | Placebo |
Primary outcome
Percentage of patients with detectable urine fluorescence using an ophtalmoscope equipped with a cobalt blue filter
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Urine Sample Authenticity
Not yet recruitingPhase 3
Study to Confirm the AuthenTicity of Point of Care Urine samplEs Using Oral fluoreScein Sodium in adulTs With substancE Use Disorder (ATTESTED)
Substance Use Disorder (SUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fluorescein sodium in people with Urine Sample Authenticity, run by UpTru Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with detectable urine fluorescence using an ophtalmoscope equipped with a cobalt blue filter (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.