Drug InteractionsNCT01859715
Emergency Department (ED) Drug Interaction in Emergency Department Patients
A study testing Oxycodone, Hydrocodone and Ondansetron in people with Drug Interactions, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Drug Interactions
- What is being tested?
- Oxycodone, Hydrocodone and Ondansetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-reported pain or nausea identified by the initial nursing assessment
Who cannot join
- unable to speak English,
- < 18 y.o.,
- previously diagnosed with chronic pain or cyclic vomiting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Cytochrome Drug Interactions in Emergency Department Patients
This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.
Read the detailed description
Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. Serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.
- Conditions
- Drug Interactions
- Being tested
- Oxycodone, Hydrocodone, Ondansetron
- Keywords
- Drug Interactions, CYP2D6, opioid efficacy, pain, nausea
- Medical subject headings
- Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Oxycodone, oxycontin
Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
HydrocodoneDrug
Also called Vicodin
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
OndansetronDrug
Also called Zofran
Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone group | Active comparator | Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization. Receives: Drug: Oxycodone |
| Nausea-observational group | Active comparator | Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only. Receives: Drug: Ondansetron |
| Hydrocodone/Acetaminophen group | Active comparator | Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. Receives: Drug: Hydrocodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.
Measured: Baseline and 90 minutes
Secondary outcomes (1)
Adverse Drug Events
Determine all possible adverse drug events that occurred after the study drugs were administered.
Measured: Duration of ED stay, <24 hours. (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew A Monte, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859715
- Sponsor's protocol ID
- 11-1692
- Status last verified
- Apr 2016
- First submitted
- 1 May 2013
- Last updated
- 5 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Cytochrome Drug Interactions in Emergency Department Patients
- ClinicalTrials.gov ID
- NCT01859715
- Acronym / sponsor ID
- 11-1692
- Conditions
- Drug Interactions
- Keywords
- Drug Interactions, CYP2D6, opioid efficacy, pain, nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Posted 5 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.
Detailed description
Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. Serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxycodone group | Active comparator | Drug: OxycodoneSubjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization. |
| Nausea-observational group | Active comparator | Drug: OndansetronPatients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only. |
| Hydrocodone/Acetaminophen group | Active comparator | Drug: HydrocodoneSubjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- self-reported pain or nausea identified by the initial nursing assessment
Key exclusion criteria (3 listed)
- unable to speak English,
- < 18 y.o.,
- previously diagnosed with chronic pain or cyclic vomiting
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 |
|---|---|---|
| OxycodoneAlso: Oxycodone, oxycontinSubjects given oxycodone 5mg by ED provider decision or by triage nurse randomization. | Drug | Oxycodone group |
| HydrocodoneAlso: VicodinSubjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. | Drug | Hydrocodone/Acetaminophen group |
| OndansetronAlso: ZofranSubjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only. | Drug | Nausea-observational group |
Primary outcome
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
Time frame: Baseline and 90 minutes
Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.
1 secondary outcome
Adverse Drug Events
Time frame: Duration of ED stay, <24 hours. (up to 24 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew A Monte, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone, Hydrocodone and Ondansetron in people with Drug Interactions, run by University of Colorado, Denver 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 1 inclusion and 3 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 5 May 2016. 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?
Yes. Results are posted in the registry (first posted 5 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users (time frame: Baseline and 90 minutes). 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 5 May 2016.