Urine ToxicologyUTOPIANCT02096172
Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA
An observational study of Urine Toxicology, run by Renaissance RX.
Trial summary
The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urine Toxicology
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jul 2014
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects who are considered candidates for UDT.
Who may be able to join
- Able to provide written informed consent
- Pharmacogenomic testing within the last 60 days
- Planned UDT
Who cannot join
- Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5
- Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST or ALT >1.5x normal, or suspected cirrhosis)
- Subject has a history of malabsorption (short gut syndrome);
- Subject has a history of any gastric or small bowel surgery;
- Subject is currently hospitalized;
- Subject is currently receiving intravenous medication.
About this study
The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).
- Conditions
- Urine Toxicology
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of CYP450 drug metabolism on quantitative UDT
Occurrence of genetically-determined abnormal metabolism of drugs tested with UDT, classified as genetic effects on metabolism (GEM) + for rapid metabolizers, GEM 0 for normal metabolizers, and GEM - for slow metabolizers.
Measured: 24 months
Secondary outcomes (6)
Occurrence of illicit drugs detected on UDT and the GEM classification associated with these medications
Measured: 24 months
Non-prescribed drugs detected on UDT and the GEM classification associated with these medications
Measured: 24 months
False positive immunoassay results, defined as positive immunoassay concurrent with negative quantitative testing
Measured: 24 months
Frequency of target drug regimen changes by the treating physician due to pharmacogenomic test results
Measured: 24 months
Frequency of illicit drug changes by the subject due to UDT results, as observed at the time of repeat UDT
Measured: 24 months
Frequency of non-prescribed drug changes by the subject due to UDT results, as detected at the time of repeat UDT
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine ToxicologyStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 0 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Renaissance RX
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096172
- Sponsor's protocol ID
- 2013-002
- Acronym
- UTOPIA
- Status last verified
- Sep 2014
- First submitted
- 21 Mar 2014
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA
- ClinicalTrials.gov ID
- NCT02096172
- Acronym / sponsor ID
- UTOPIA / 2013-002
- Conditions
- Urine Toxicology
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Renaissance RXIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).
Study design
- Observational model
- Cohort
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects who are considered candidates for UDT.
Key inclusion criteria (3 listed)
- Able to provide written informed consent
- Pharmacogenomic testing within the last 60 days
- Planned UDT
Key exclusion criteria (6 listed)
- Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5
- Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST or ALT >1.5x normal, or suspected cirrhosis)
- Subject has a history of malabsorption (short gut syndrome);
- Subject has a history of any gastric or small bowel surgery;
- Subject is currently hospitalized;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Influence of CYP450 drug metabolism on quantitative UDT
Time frame: 24 months
Occurrence of genetically-determined abnormal metabolism of drugs tested with UDT, classified as genetic effects on metabolism (GEM) + for rapid metabolizers, GEM 0 for normal metabolizers, and GEM - for slow metabolizers.
6 secondary outcomes
Occurrence of illicit drugs detected on UDT and the GEM classification associated with these medications
Time frame: 24 months
Non-prescribed drugs detected on UDT and the GEM classification associated with these medications
Time frame: 24 months
False positive immunoassay results, defined as positive immunoassay concurrent with negative quantitative testing
Time frame: 24 months
Frequency of target drug regimen changes by the treating physician due to pharmacogenomic test results
Time frame: 24 months
Frequency of illicit drug changes by the subject due to UDT results, as observed at the time of repeat UDT
Time frame: 24 months
Frequency of non-prescribed drug changes by the subject due to UDT results, as detected at the time of repeat UDT
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2014.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urine Toxicology, run by Renaissance RX.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Influence of CYP450 drug metabolism on quantitative UDT (time frame: 24 months). 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 23 Sep 2014.