HealthyNCT01061112
Effects of Genotype on CYP2C9 Drug Interactions
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
This research study will help determine how a person's genetic makeup affects their responses to drugs, the ability of the body to break down drugs, and their potential to experience an interaction between drugs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flurbiprofen Inhibition - Flurbiprofen & Fluconazole and Ketoprofen Inhibition - Ketoprofen & Fluconazole
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2014
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects are selected from a pharmacogenetics registry in which their drug metabolism genotype has been determined.
Who may be able to join
- Subjects will be 18-60 years old.
- Women of child-bearing age must be willing to use measures to avoid conception during the study period.
- Subjects must agree not to take any known substrates, inhibitors, inducers, or activators of CYP2C9.
Who cannot join
- Current cigarette smoker.
- Abnormal renal or liver function tests, physical exam, or recent history of hepatic, renal, gastrointestinal or neoplastic disease.
- Allergy to tolbutamide, flurbiprofen, ketoprofen, fluconazole or phenytoin and other chemically related drugs.
- Recent ingestion (< 1 week) of any medication known to be metabolized by or alter activity of CYP2C9.
- A positive pregnancy test during the time of the pharmacokinetic study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Science Institute
Minneapolis, Minnesota, 55414
About this study
This research study will help determine how a person's genetic makeup affects their responses to drugs, the ability of the body to break down drugs, and their potential to experience an interaction between drugs. We are investigating the drug interactions between an antifungal drug called fluconazole and the commonly used drugs tolbutamide, flurbiprofen, and ketoprofen. Tolbutamide is used for management of Type 2 diabetes. Both flurbiprofen and ketoprofen are non-steroidal anti-inflammatory drugs (NSAIDs) often used for arthritis or pain. We are interested in studying whether individuals with certain genetic profiles have different drug interactions than normal. This research is being done to see if certain genetic profiles require us to adjust medication doses differently than is needed for the general population. Genetic profiles of subjects are determined from their previous participation in the Pharmacogenetics Registry (Investigator Richard Brundage, University of Minnesota).
The study hypothesis is: Fraction metabolized by CYP2C9 enzyme determines the extent of drug interactions in CYP2C9*1/*1 individuals but this factor (fraction metabolized) becomes less influential and drug interactions are attenuated in a gene-dose dependent manner in individuals with one or more defective alleles.
Read the detailed description
The study hypothesis is: Fraction metabolized by CYP2C9 enzyme determines the extent of drug interactions in CYP2C9*1/*1 individuals but this factor (fraction metabolized) becomes less influential and drug interactions are attenuated in a gene-dose dependent manner in individuals with one or more defective alleles.
Objective: Examine the extent of fluconazole inhibition of drugs with varying degrees of fraction metabolized by CYP2C9 in individuals with the CYP2C9*1/*1, CYP2C9*1/*3 and CYP2C9*3/*3 genotypes.
People differ in their genetic makeup. This includes differences in genes involved in drug metabolism, transport, and effect in the body. People with certain genetic profiles produce altered enzymes, transporters, and receptors that may respond in different ways to drugs. Altered enzymes cause some drugs to be broken down at a different rate than normal. As a result, drug concentrations build up in the blood, and increase the risk of side effects. Furthermore, when two drugs are taken together, the possibility exists for the drugs to interact, with one drug causing a change in the metabolism of the other or both of the drugs. It is not known whether people with an altered genetic makeup also have an altered experience with drug interactions. Altered drug transporters can affect the absorption and elimination of drugs as compared to normal causing differences in how long the drug stays in the body. Finally, altered drug receptors can respond differently to drugs and, thus, produce altered desired or undesired effects.
In this study, we will be investigating the drug interactions between an antifungal drug called fluconazole and the commonly used drugs tolbutamide, flurbiprofen, and ketoprofen in subjects with three different genotypes of the CYP2C9 enzyme. Tolbutamide is used for management of Type 2 diabetes. Both flurbiprofen and ketoprofen are non-steroidal anti-inflammatory drugs (NSAIDs) often used for arthritis or pain. We are interested in studying whether individuals with certain genetic profiles have different drug interactions than normal. This research is being done to see if certain genetic profiles require us to adjust medication doses differently than is needed for the general population.
The cytochrome P450 (CYP) superfamily of enzymes plays an important role in the oxidative conversion of numerous xenobiotics into their more hydrophilic metabolites. CYP2C9, is an important member of the CYP superfamily, accounting for 10-20% of the CYP protein content in human liver and catalyzes approximately 20% of the CYP mediated drug oxidation reactions, including tolbutamide and the non-steroidal anti-inflammatory drugs (NSAIDs) such as ketoprofen and flurbiprofen. It is now well established that genetic factors play an important role in the control of CYP2C9 expression and activity. In particular, the *3 allele is expressed at an allele frequency of 15%. Homozygotic *3 individuals exhibit significantly reduced oral clearance for several CYP2C9 substrates. In most of these cases, the reduction in clearance approaches 80% and even in heterozygotic individuals, this reduction in clearance is 40-50% due to the co-dominant expression of CYP2C9. This reduction in clearance has been associated with an increased frequency of adverse events following warfarin or phenytoin administration, two clinically important drugs that exhibit a narrow therapeutic index. The therapeutic index is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxic effects.
- Conditions
- Healthy
- Being tested
- Flurbiprofen Control - Flurbiprofen Only, Flurbiprofen Inhibition - Flurbiprofen & Fluconazole, Ketoprofen Control - Ketoprofen Only, Ketoprofen Inhibition - Ketoprofen & Fluconazole, Tolbutamide Control - Tolbutamide Only
- Keywords
- Drug Interactions, Genetics, CYP2C9, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flurbiprofen Control - Flurbiprofen OnlyDrug
Also called Ansaid
A single 50 mg flurbiprofen dose taken at the start of the study period. No other drugs administered during this study period.
Flurbiprofen Inhibition - Flurbiprofen & FluconazoleDrug
Also called Ansaid, Diflucan
A single 50 mg flurbiprofen dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
Ketoprofen Control - Ketoprofen OnlyDrug
Also called Orudis
A single 75 mg ketoprofen dose taken at the start of the study period. No other drugs administered during this study period.
Ketoprofen Inhibition - Ketoprofen & FluconazoleDrug
Also called Orudis, Diflucan
A single 75 mg ketoprofen dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
Tolbutamide Control - Tolbutamide OnlyDrug
Also called Orinase
A single 500 mg tolbutamide dose taken at the start of the study period. No other drugs administered during this study period.
Tolbutamide Inhibition - Tolbutamide & FluconazoleDrug
Also called Orinase, Diflucan
A single 500 mg tolbutamide dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| CYP2C9*1/*1 Genotype | This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following interventions: Flurbiprofen Control - Flurbiprofen Only, Flurbiprofen Inhibition - Flurbiprofen \& Fluconazole, Ketoprofen Control - Ketoprofen Only, Ketoprofen Inhibition - Ketoprofen \& Fluconazole, Tolbutamide Control - Tolbutamide Only, and Tolbutamide Inhibition - Tolbutamide \& Fluconazole. Receives: Drug: Flurbiprofen Control - Flurbiprofen Only; Drug: Flurbiprofen Inhibition - Flurbiprofen & Fluconazole; Drug: Ketoprofen Control - Ketoprofen Only; Drug: Ketoprofen Inhibition - Ketoprofen & Fluconazole; Drug: Tolbutamide Control - Tolbutamide Only; Drug: Tolbutamide Inhibition - Tolbutamide & Fluconazole | |
| CYP2C9*1/*3 Genotype | Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following interventions: Flurbiprofen Control - Flurbiprofen Only, Flurbiprofen Inhibition - Flurbiprofen \& Fluconazole, Ketoprofen Control - Ketoprofen Only, Ketoprofen Inhibition - Ketoprofen \& Fluconazole, Tolbutamide Control - Tolbutamide Only, and Tolbutamide Inhibition - Tolbutamide \& Fluconazole. Receives: Drug: Flurbiprofen Control - Flurbiprofen Only; Drug: Flurbiprofen Inhibition - Flurbiprofen & Fluconazole; Drug: Ketoprofen Control - Ketoprofen Only; Drug: Ketoprofen Inhibition - Ketoprofen & Fluconazole; Drug: Tolbutamide Control - Tolbutamide Only; Drug: Tolbutamide Inhibition - Tolbutamide & Fluconazole | |
| CYP2C9*3/*3 Genotype | Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following interventions: Flurbiprofen Control - Flurbiprofen Only, Flurbiprofen Inhibition - Flurbiprofen \& Fluconazole, Ketoprofen Control - Ketoprofen Only, Ketoprofen Inhibition - Ketoprofen \& Fluconazole, Tolbutamide Control - Tolbutamide Only, and Tolbutamide Inhibition - Tolbutamide \& Fluconazole. Receives: Drug: Flurbiprofen Control - Flurbiprofen Only; Drug: Flurbiprofen Inhibition - Flurbiprofen & Fluconazole; Drug: Ketoprofen Control - Ketoprofen Only; Drug: Ketoprofen Inhibition - Ketoprofen & Fluconazole; Drug: Tolbutamide Control - Tolbutamide Only; Drug: Tolbutamide Inhibition - Tolbutamide & Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flurbiprofen Clearance
Measure of blood concentrations of Flurbiprofen 48 hours post Flurbiprofen dose
Measured: 48 hours post Flurbiprofen dose
Ketoprofen Clearance
Measure of blood concentrations of Ketoprofen 48 hours post Ketoprofen dose
Measured: 48 hours post Ketoprofen dose
Tolbutamide Clearance
Measure of blood concentrations of Tolbutamide 48 hours post Tolbutamide dose
Measured: 48 hours post Tolbutamide dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Richard Brundage, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061112
- Sponsor's protocol ID
- 0812M56082
- Other IDs
- R01GM069753
- Status last verified
- Jul 2019
- First submitted
- 29 Jan 2010
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Genotype on CYP2C9 Drug Interactions
- ClinicalTrials.gov ID
- NCT01061112
- Acronym / sponsor ID
- 0812M56082
- Conditions
- Healthy
- Keywords
- Drug Interactions, Genetics, CYP2C9, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Dec 2009 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Feb 2010 (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.
This research study will help determine how a person's genetic makeup affects their responses to drugs, the ability of the body to break down drugs, and their potential to experience an interaction between drugs. We are investigating the drug interactions between an antifungal drug called fluconazole and the commonly used drugs tolbutamide, flurbiprofen, and ketoprofen. Tolbutamide is used for management of Type 2 diabetes. Both flurbiprofen and ketoprofen are non-steroidal anti-inflammatory drugs (NSAIDs) often used for arthritis or pain. We are interested in studying whether individuals with certain genetic profiles have different drug interactions than normal. This research is being done to see if certain genetic profiles require us to adjust medication doses differently than is needed for the general population. Genetic profiles of subjects are determined from their previous participation in the Pharmacogenetics Registry (Investigator Richard Brundage, University of Minnesota).
The study hypothesis is: Fraction metabolized by CYP2C9 enzyme determines the extent of drug interactions in CYP2C9*1/*1 individuals but this factor (fraction metabolized) becomes less influential and drug interactions are attenuated in a gene-dose dependent manner in individuals with one or more defective alleles.
Detailed description
The study hypothesis is: Fraction metabolized by CYP2C9 enzyme determines the extent of drug interactions in CYP2C9*1/*1 individuals but this factor (fraction metabolized) becomes less influential and drug interactions are attenuated in a gene-dose dependent manner in individuals with one or more defective alleles.
Objective: Examine the extent of fluconazole inhibition of drugs with varying degrees of fraction metabolized by CYP2C9 in individuals with the CYP2C9*1/*1, CYP2C9*1/*3 and CYP2C9*3/*3 genotypes.
People differ in their genetic makeup. This includes differences in genes involved in drug metabolism, transport, and effect in the body. People with certain genetic profiles produce altered enzymes, transporters, and receptors that may respond in different ways to drugs. Altered enzymes cause some drugs to be broken down at a different rate than normal. As a result, drug concentrations build up in the blood, and increase the risk of side effects. Furthermore, when two drugs are taken together, the possibility exists for the drugs to interact, with one drug causing a change in the metabolism of the other or both of the drugs. It is not known whether people with an altered genetic makeup also have an altered experience with drug interactions. Altered drug transporters can affect the absorption and elimination of drugs as compared to normal causing differences in how long the drug stays in the body. Finally, altered drug receptors can respond differently to drugs and, thus, produce altered desired or undesired effects.
In this study, we will be investigating the drug interactions between an antifungal drug called fluconazole and the commonly used drugs tolbutamide, flurbiprofen, and ketoprofen in subjects with three different genotypes of the CYP2C9 enzyme. Tolbutamide is used for management of Type 2 diabetes. Both flurbiprofen and ketoprofen are non-steroidal anti-inflammatory drugs (NSAIDs) often used for arthritis or pain. We are interested in studying whether individuals with certain genetic profiles have different drug interactions than normal. This research is being done to see if certain genetic profiles require us to adjust medication doses differently than is needed for the general population.
The cytochrome P450 (CYP) superfamily of enzymes plays an important role in the oxidative conversion of numerous xenobiotics into their more hydrophilic metabolites. CYP2C9, is an important member of the CYP superfamily, accounting for 10-20% of the CYP protein content in human liver and catalyzes approximately 20% of the CYP mediated drug oxidation reactions, including tolbutamide and the non-steroidal anti-inflammatory drugs (NSAIDs) such as ketoprofen and flurbiprofen. It is now well established that genetic factors play an important role in the control of CYP2C9 expression and activity. In particular, the *3 allele is expressed at an allele frequency of 15%. Homozygotic *3 individuals exhibit significantly reduced oral clearance for several CYP2C9 substrates. In most of these cases, the reduction in clearance approaches 80% and even in heterozygotic individuals, this reduction in clearance is 40-50% due to the co-dominant expression of CYP2C9. This reduction in clearance has been associated with an increased frequency of adverse events following warfarin or phenytoin administration, two clinically important drugs that exhibit a narrow therapeutic index. The therapeutic index is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxic effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CYP2C9*1/*1 Genotype | – | Drug: Flurbiprofen Control - Flurbiprofen Only, Drug: Flurbiprofen Inhibition - Flurbiprofen & Fluconazole, Drug: Ketoprofen Control - Ketoprofen Only, Drug: Ketoprofen Inhibition - Ketoprofen & Fluconazole, Drug: Tolbutamide Control - Tolbutamide Only, Drug: Tolbutamide Inhibition - Tolbutamide & FluconazoleThis genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following interventions: Flurbiprofen Control - Flurbiprofen Only, Flurbiprofen Inhibition - Flurbiprofen \& Fluconazole, Ketoprofen Control - Ketoprofen Only, Ketoprofen Inhibition - Ketoprofen \& Fluconazole, Tolbutamide Control - Tolbutamide Only, and Tolbutamide Inhibition - Tolbutamide \& Fluconazole. |
| CYP2C9*1/*3 Genotype | – | Drug: Flurbiprofen Control - Flurbiprofen Only, Drug: Flurbiprofen Inhibition - Flurbiprofen & Fluconazole, Drug: Ketoprofen Control - Ketoprofen Only, Drug: Ketoprofen Inhibition - Ketoprofen & Fluconazole, Drug: Tolbutamide Control - Tolbutamide Only, Drug: Tolbutamide Inhibition - Tolbutamide & FluconazoleIndividuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following interventions: Flurbiprofen Control - Flurbiprofen Only, Flurbiprofen Inhibition - Flurbiprofen \& Fluconazole, Ketoprofen Control - Ketoprofen Only, Ketoprofen Inhibition - Ketoprofen \& Fluconazole, Tolbutamide Control - Tolbutamide Only, and Tolbutamide Inhibition - Tolbutamide \& Fluconazole. |
| CYP2C9*3/*3 Genotype | – | Drug: Flurbiprofen Control - Flurbiprofen Only, Drug: Flurbiprofen Inhibition - Flurbiprofen & Fluconazole, Drug: Ketoprofen Control - Ketoprofen Only, Drug: Ketoprofen Inhibition - Ketoprofen & Fluconazole, Drug: Tolbutamide Control - Tolbutamide Only, Drug: Tolbutamide Inhibition - Tolbutamide & FluconazoleIndividuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following interventions: Flurbiprofen Control - Flurbiprofen Only, Flurbiprofen Inhibition - Flurbiprofen \& Fluconazole, Ketoprofen Control - Ketoprofen Only, Ketoprofen Inhibition - Ketoprofen \& Fluconazole, Tolbutamide Control - Tolbutamide Only, and Tolbutamide Inhibition - Tolbutamide \& Fluconazole. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects are selected from a pharmacogenetics registry in which their drug metabolism genotype has been determined.
Key inclusion criteria (3 listed)
- Subjects will be 18-60 years old.
- Women of child-bearing age must be willing to use measures to avoid conception during the study period.
- Subjects must agree not to take any known substrates, inhibitors, inducers, or activators of CYP2C9.
Key exclusion criteria (5 listed)
- Current cigarette smoker.
- Abnormal renal or liver function tests, physical exam, or recent history of hepatic, renal, gastrointestinal or neoplastic disease.
- Allergy to tolbutamide, flurbiprofen, ketoprofen, fluconazole or phenytoin and other chemically related drugs.
- Recent ingestion (< 1 week) of any medication known to be metabolized by or alter activity of CYP2C9.
- A positive pregnancy test during the time of the pharmacokinetic 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 |
|---|---|---|
| Flurbiprofen Control - Flurbiprofen OnlyAlso: AnsaidA single 50 mg flurbiprofen dose taken at the start of the study period. No other drugs administered during this study period. | Drug | CYP2C9*1/*1 Genotype, CYP2C9*1/*3 Genotype, CYP2C9*3/*3 Genotype |
| Flurbiprofen Inhibition - Flurbiprofen & FluconazoleAlso: Ansaid, DiflucanA single 50 mg flurbiprofen dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period. | Drug | CYP2C9*1/*1 Genotype, CYP2C9*1/*3 Genotype, CYP2C9*3/*3 Genotype |
| Ketoprofen Control - Ketoprofen OnlyAlso: OrudisA single 75 mg ketoprofen dose taken at the start of the study period. No other drugs administered during this study period. | Drug | CYP2C9*1/*1 Genotype, CYP2C9*1/*3 Genotype, CYP2C9*3/*3 Genotype |
| Ketoprofen Inhibition - Ketoprofen & FluconazoleAlso: Orudis, DiflucanA single 75 mg ketoprofen dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period. | Drug | CYP2C9*1/*1 Genotype, CYP2C9*1/*3 Genotype, CYP2C9*3/*3 Genotype |
| Tolbutamide Control - Tolbutamide OnlyAlso: OrinaseA single 500 mg tolbutamide dose taken at the start of the study period. No other drugs administered during this study period. | Drug | CYP2C9*1/*1 Genotype, CYP2C9*1/*3 Genotype, CYP2C9*3/*3 Genotype |
| Tolbutamide Inhibition - Tolbutamide & FluconazoleAlso: Orinase, DiflucanA single 500 mg tolbutamide dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period. | Drug | CYP2C9*1/*1 Genotype, CYP2C9*1/*3 Genotype, CYP2C9*3/*3 Genotype |
Primary outcome
Flurbiprofen Clearance
Time frame: 48 hours post Flurbiprofen dose
Measure of blood concentrations of Flurbiprofen 48 hours post Flurbiprofen dose
Ketoprofen Clearance
Time frame: 48 hours post Ketoprofen dose
Measure of blood concentrations of Ketoprofen 48 hours post Ketoprofen dose
Tolbutamide Clearance
Time frame: 48 hours post Tolbutamide dose
Measure of blood concentrations of Tolbutamide 48 hours post Tolbutamide dose
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 18 Jul 2019.
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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.
Richard Brundage, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
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 5 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 18 Jul 2019. 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 United States. 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. 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 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?
Flurbiprofen Clearance (time frame: 48 hours post Flurbiprofen dose). The study lists 3 primary outcomes in all. 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 18 Jul 2019.