PainNCT02901054
CSF Pharmacokinetics of Ondansetron
A study testing Ondansetron in people with Pain, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2016to 17 Nov 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years old;
- Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
- Ability to provide informed consent
Who cannot join
- Not giving consent to participate in the study;
- Patients with history of or current hepatic or renal insufficiency;
- Patients with BMI ≥ 33;
- Patients with heart failure or active arrhythmias;
- Patients with severe systemic disease that is a constant threat to life;
- Contraindication or allergy to ondansetron;
- Pregnancy or lactation.
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron
Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution.
Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.
- Conditions
- Pain
- Being tested
- Ondansetron
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
A single 15-min intravenous infusion of ondansetron
| Study group | Role | What they receive |
|---|---|---|
| open label infusion ondansetron | Experimental | 1. A single 4-mL CSF sample per subject.
2. Serial blood sampling at 0 (pre-infusion), 15, 30, 60, 120, and 180 min after ondansetron administration Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF to Plasma Concentration Ratio
CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample
Measured: 0-180 min from the beginning of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start25 Aug 2016
- Primary completion17 Nov 2016
- Study completion17 Nov 2016
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 PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, simon.haroutounian, Washington University School of Medicine
- Investigators
- Simon Haroutounian, PhD, Principal investigator, Dept of Anesthesiology, Washington Univ School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901054
- Sponsor's protocol ID
- 201605080
- Status last verified
- Dec 2019
- First submitted
- 4 Sep 2016
- Last updated
- 27 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron
- ClinicalTrials.gov ID
- NCT02901054
- Acronym / sponsor ID
- 201605080
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Aug 2016 (actual)
- Primary completion
- 17 Nov 2016 (actual)
- Study completion
- 17 Nov 2016 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 16 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution.
Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label infusion ondansetron | Experimental | Drug: Ondansetron1. A single 4-mL CSF sample per subject. 2. Serial blood sampling at 0 (pre-infusion), 15, 30, 60, 120, and 180 min after ondansetron administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years old;
- Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Not giving consent to participate in the study;
- Patients with history of or current hepatic or renal insufficiency;
- Patients with BMI ≥ 33;
- Patients with heart failure or active arrhythmias;
- Patients with severe systemic disease that is a constant threat to life;
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 |
|---|---|---|
| OndansetronAlso: ZofranA single 15-min intravenous infusion of ondansetron | Drug | open label infusion ondansetron |
Primary outcome
CSF to Plasma Concentration Ratio
Time frame: 0-180 min from the beginning of infusion
CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Simon Haroutounian, PhD principal investigator
Dept of Anesthesiology, Washington Univ School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron in people with Pain, run by Washington University School of Medicine 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 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 27 Dec 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?
Yes. Results are posted in the registry (first posted 16 May 2018). 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?
CSF to Plasma Concentration Ratio (time frame: 0-180 min from the beginning of infusion). 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 27 Dec 2019.