Osteoarthritis, KneePhase 2NCT04429880
A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects
A Phase 2 study testing Oxytocin in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences.
Trial summary
The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK) of oxytocin. This is an unblinded, sequential study of subjects, all of whom will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain) with blood samples taken thereafter in… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
- 2. Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3.
- 3. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
- 4. Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Who cannot join
- 1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- 2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- 3. Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
- 4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
About this study
Official title: A Study of Oxytocin Pharmacokinetics After Intravenous Administration in Healthy Subjects and Advanced Knee Arthritis Subjects
The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK) of oxytocin.
This is an unblinded, sequential study of subjects, all of whom will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain) with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics).
Read more
In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Each study participant will have 2 IV catheters placed (one in each arm). After placement of the IV catheters and infusion of oxytocin will be given over a 10 minute period. Blood samples will be taken before the infusion begins and several times during and after the infusion. The blood will be drawn through the second IV catheter.
The investigators will also do some tests to get a rough idea of how oxytocin changes perceptions on the skin and how this relates to the amount of oxytocin in the blood at the same time. Two kinds of perceptions will be studied. First, the investigators will study a painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. Secondly, the investigators will study the perception of vibration, like one feels with a tuning fork on the skin. For this the investigators will put a controlled vibration device on the arm and start the vibration at such a high frequency (1000 times per second) that it cannot be felt as vibrating. The investigators will slow the frequency until the study participant first feels vibration, then turn off the machine and record this threshold frequency where it is first felt.
Read the detailed description
This is an unblinded, sequential study of subjects; all participants will receive an infusion of oxytocin with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics). In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Participants will come to the Clinical Research Unit (CRU) and have two IVs inserted; one in each arm. Participants will get a 10 minute infusion through one of the IVs of oxytocin and blood will be taken several times over the next 120 minutes and the amount of oxytocin measured in the blood samples. This information will be analyzed by another group at Stanford University in the Pharmacokinetics/Pharmacodynamics (PK/PD) Core part of this application. Mathematics will be utilized to fit the amount of oxytocin over time as it disappears from blood to a formula, called pharmacokinetics. The effect of subject age, sex, race, ethnicity and weight on the pharmacokinetics of oxytocin will be tested for, since these things can affect how quickly drugs circulate in the blood and are important to better adjust the dose of drug to the individual.
The main purpose of this study is to sample the blood and calculate the pharmacokinetics of oxytocin. Investigators will also do some tests to get a rough idea of how oxytocin changes perceptions on the skin and how this relates to the amount of oxytocin in the blood at the same time. Two kinds of perceptions will be studied. In the first the study team will study a painful perception by placing a probe on the skin and heating it to 113 degrees F for 5 minutes. Subjects will score any pain felt on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. In the second, the study team will study the perception of vibration, like one feels with a tuning fork on the skin. For this the study team will put a controlled vibration device on the arm and start the vibration at such a high frequency (1000 times per second) that it cannot be felt as vibrating. The study team will slow the frequency until the subject first feels vibration, then turn off the machine and record this threshold frequency where the participant first feels it. Investigators do these two tests because they test the response of two kinds of nerve fibers - pain fibers and touch fibers - which oxytocin might affect in different ways. With this information investigators will compare the amount of oxytocin in blood over time to its effects on pain and vibration over time using mathematics.
The research participants will not benefit from this study, but the knowledge investigators get will be important not only to adjust oxytocin dose to individuals, but to study its possible effects on pain in a very standardized way. The sample size chosen is needed to get an accurate estimate for the parameters in the pharmacokinetic model for the population, not just the subjects in this study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Oxytocin
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Oxytocin given by intravenous route
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin 17 micrograms infusion over 10 minutes Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 1 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 2 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 5 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 10 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 12 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 15 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 20 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 30 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 60 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 90 minute after oxytocin infusion initiated
Pharmacokinetics of oxytocin in serum
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Measured: 120 minute after oxytocin infusion initiated
Secondary outcomes (10)
Pharmacodynamics of heat pain after oxytocin
Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Measured: 30 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined,pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Measured: 60 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Measured: 90 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Measured: 120 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Measured: 180 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
Measured: 30 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
Measured: 60 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
Measured: 90 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Threshold frequency for detection of vibration will be determined. Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
Measured: 120 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
Measured: 180 minutes after oxytocin infusion initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Study was not initiated; no subjects enrolled. A replacement study will be submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will receive the same dose of oxytocin 17 micrograms via a 10 minute intravenous infusion
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Eisenach, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429880
- Sponsor's protocol ID
- IRB00065787
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2020
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Oxytocin Pharmacokinetics After Intravenous Administration in Healthy Subjects and Advanced Knee Arthritis Subjects
- ClinicalTrials.gov ID
- NCT04429880
- Acronym / sponsor ID
- IRB00065787
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated; no subjects enrolled. A replacement study will be submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 12 Jun 2020 (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.
The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK) of oxytocin.
This is an unblinded, sequential study of subjects, all of whom will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain) with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics).
In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Each study participant will have 2 IV catheters placed (one in each arm). After placement of the IV catheters and infusion of oxytocin will be given over a 10 minute period. Blood samples will be taken before the infusion begins and several times during and after the infusion. The blood will be drawn through the second IV catheter.
The investigators will also do some tests to get a rough idea of how oxytocin changes perceptions on the skin and how this relates to the amount of oxytocin in the blood at the same time. Two kinds of perceptions will be studied. First, the investigators will study a painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. Secondly, the investigators will study the perception of vibration, like one feels with a tuning fork on the skin. For this the investigators will put a controlled vibration device on the arm and start the vibration at such a high frequency (1000 times per second) that it cannot be felt as vibrating. The investigators will slow the frequency until the study participant first feels vibration, then turn off the machine and record this threshold frequency where it is first felt.
Detailed description
This is an unblinded, sequential study of subjects; all participants will receive an infusion of oxytocin with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics). In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Participants will come to the Clinical Research Unit (CRU) and have two IVs inserted; one in each arm. Participants will get a 10 minute infusion through one of the IVs of oxytocin and blood will be taken several times over the next 120 minutes and the amount of oxytocin measured in the blood samples. This information will be analyzed by another group at Stanford University in the Pharmacokinetics/Pharmacodynamics (PK/PD) Core part of this application. Mathematics will be utilized to fit the amount of oxytocin over time as it disappears from blood to a formula, called pharmacokinetics. The effect of subject age, sex, race, ethnicity and weight on the pharmacokinetics of oxytocin will be tested for, since these things can affect how quickly drugs circulate in the blood and are important to better adjust the dose of drug to the individual.
The main purpose of this study is to sample the blood and calculate the pharmacokinetics of oxytocin. Investigators will also do some tests to get a rough idea of how oxytocin changes perceptions on the skin and how this relates to the amount of oxytocin in the blood at the same time. Two kinds of perceptions will be studied. In the first the study team will study a painful perception by placing a probe on the skin and heating it to 113 degrees F for 5 minutes. Subjects will score any pain felt on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. In the second, the study team will study the perception of vibration, like one feels with a tuning fork on the skin. For this the study team will put a controlled vibration device on the arm and start the vibration at such a high frequency (1000 times per second) that it cannot be felt as vibrating. The study team will slow the frequency until the subject first feels vibration, then turn off the machine and record this threshold frequency where the participant first feels it. Investigators do these two tests because they test the response of two kinds of nerve fibers - pain fibers and touch fibers - which oxytocin might affect in different ways. With this information investigators will compare the amount of oxytocin in blood over time to its effects on pain and vibration over time using mathematics.
The research participants will not benefit from this study, but the knowledge investigators get will be important not only to adjust oxytocin dose to individuals, but to study its possible effects on pain in a very standardized way. The sample size chosen is needed to get an accurate estimate for the parameters in the pharmacokinetic model for the population, not just the subjects in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will receive the same dose of oxytocin 17 micrograms via a 10 minute intravenous infusion
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinOxytocin 17 micrograms infusion over 10 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
- 2. Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3.
- 3. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
- 4. Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Key exclusion criteria (4 listed)
- 1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- 2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- 3. Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
- 4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
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 |
|---|---|---|
| OxytocinAlso: PitocinOxytocin given by intravenous route | Drug | Oxytocin |
Primary outcome
Pharmacokinetics of oxytocin in serum
Time frame: 1 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 2 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 5 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 10 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 12 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 15 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 20 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 30 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 60 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 90 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
Pharmacokinetics of oxytocin in serum
Time frame: 120 minute after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
10 secondary outcomes
Pharmacodynamics of heat pain after oxytocin
Time frame: 30 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Time frame: 60 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Time frame: 90 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Time frame: 120 minutes after oxytocin infusion initiated
Pharmacodynamics of heat pain after oxytocin
Time frame: 180 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Time frame: 30 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Time frame: 60 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Time frame: 90 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Time frame: 120 minutes after oxytocin infusion initiated
Pharmacodynamics of vibration perception after oxytocin
Time frame: 180 minutes after oxytocin infusion initiated
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 12 Aug 2025.
- 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.
James C Eisenach, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences.
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 4 inclusion and 4 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 12 Aug 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Pharmacokinetics of oxytocin in serum (time frame: 1 minute after oxytocin infusion initiated). The study lists 11 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 12 Aug 2025.