Osteoarthritis, KneePhase 2NCT04431193
Estimate Serum Oxytocin PD Range in the Periphery
A Phase 2 study testing Oxytocin in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The main purpose of this study is to define the maximum effect oxytocin (naturally occurring hormone that is made in the brain) has on pain from a 5 minute heat probe applied to the skin and to get an estimate for the relationship between the amount of pain relief at different amounts of oxytocin in the blood. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to Mar 2025
- 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
- Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
- 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.
- 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.
- 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
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- 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
- 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
- Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Estimate Serum Oxytocin Pharmacodynamic Range in the Periphery
The main purpose of this study is to define the maximum effect oxytocin (naturally occurring hormone that is made in the brain) has on pain from a 5 minute heat probe applied to the skin and to get an estimate for the relationship between the amount of pain relief at different amounts of oxytocin in the blood.
This is a study of participants that 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 there is a need for a 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, 4 different levels of oxytocin will be given by IV infusion. Blood samples will be taken before the infusion begins and after each different level of the infusion. The blood will be drawn through the second IV catheter.
The study team 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. The study team 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.
Read the detailed description
This is an unblinded, sequential study in which all participants will receive intravenous (IV) infusions of oxytocin in the same manner (except for safety reasons an adjustment at the highest level after review of the first 7 study participants as indicated in safety plan). In this study healthy people and with those with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will come to the Clinical Research Unit (CRU) and two IVs inserted; one in each forearm. Study participants will have an intravenous infusion of oxytocin at infusion rates that will result in a steady concentration of oxytocin in the blood for 15 minutes. The infusion rate will be increased every 15 minutes for a total of 4 targeted levels. Blood (5 millilitres (ml)) will be withdrawn through the IV not being used for infusion at the end of each of these infusion levels 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. The core group at Stanford University will use mathematics to test the accuracy of the infusion to target the blood concentration.
The main purpose of this study is to define the maximum effect oxytocin has on pain from a 5 minute heat probe applied to the skin and to get an estimate for the relationship between the amounts of pain relief at different amounts of oxytocin in the blood. The study team will use a commercially available device (Medoc TSA II) to heat a probe on the skin to 113 degrees Fahrenheit (45 degrees Celsius) for 5 minutes. Study participants will score any pain noted 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. The study team will do this 5 times during the study, once before the infusion and once during each of the 4 levels of infusion. From this the study team will calculate how the amount of oxytocin in the blood affects pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Oxytocin
- Keywords
- advanced knee arthritis
- 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 infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin 4 picogram/millilitre | Experimental | Oxytocin infused to maintain serum concentration of 4 picogram/millilitre Receives: Drug: Oxytocin |
| Oxytocin 16 picogram/millilitre | Experimental | Oxytocin infused to maintain serum concentration of 16 picogram/millilitre Receives: Drug: Oxytocin |
| Oxytocin 64 picogram/millilitre | Experimental | Oxytocin infused to maintain serum concentration of 64 picogram/millilitre Receives: Drug: Oxytocin |
| Oxytocin 256 picogram/millilitre | Experimental | Oxytocin infused to maintain serum concentration of 256 picogram/millilitre Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics of heat pain after oxytocin
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: Baseline before any infusion 0 minutes
Pharmacodynamics of heat pain oxytocin 16 pg/ml
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: Before Oxytocin infusion 15 minutes after baseline
Pharmacodynamics of heat pain oxytocin 64 pg/ml
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: Before Oxytocin infusion 30 minutes after baseline
Pharmacodynamics of heat pain oxytocin 256 pg/ml
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: Before Oxytocin infusion 45 minutes after baseline
Pharmacodynamics of heat pain oxytocin 4pg/ml
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: After Oxytocin infusion 14 minutes after baseline
Pharmacodynamics of heat pain oxytocin 16 pg/ml
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: After Oxytocin infusion 29 minutes after baseline
Pharmacodynamics of heat pain oxytocin 64pg/ml
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: After Oxytocin infusion 44 minutes after baseline
Pharmacodynamics of heat pain oxytocin 256 pg/ml
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: After Oxytocin infusion 59 minutes after baseline
Secondary outcomes (4)
Pharmacokinetics of oxytocin in serum 4pg/ml
Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
Measured: After Oxytocin infusion 15 minutes after baseline
Pharmacokinetics of oxytocin in serum 16 pg/ml
Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
Measured: After Oxytocin infusion 30 minutes after baseline
Pharmacokinetics of oxytocin in serum 64pg/ml
Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
Measured: After Oxytocin infusion 45 minutes after baseline
Pharmacokinetics of oxytocin in serum 256pg/ml
Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
Measured: After Oxytocin infusion 60 minutes after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study startDec 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: Study will be replaced by a revised study protocol
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre
- 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
- NCT04431193
- Sponsor's protocol ID
- IRB00066130
- Status last verified
- May 2022
- First submitted
- 5 Jun 2020
- Last updated
- 30 Dec 2022
- 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 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimate Serum Oxytocin Pharmacodynamic Range in the Periphery
- ClinicalTrials.gov ID
- NCT04431193
- Acronym / sponsor ID
- IRB00066130
- Conditions
- Osteoarthritis, Knee
- Keywords
- advanced knee arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will be replaced by a revised study protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 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 define the maximum effect oxytocin (naturally occurring hormone that is made in the brain) has on pain from a 5 minute heat probe applied to the skin and to get an estimate for the relationship between the amount of pain relief at different amounts of oxytocin in the blood.
This is a study of participants that 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 there is a need for a 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, 4 different levels of oxytocin will be given by IV infusion. Blood samples will be taken before the infusion begins and after each different level of the infusion. The blood will be drawn through the second IV catheter.
The study team 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. The study team 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.
Detailed description
This is an unblinded, sequential study in which all participants will receive intravenous (IV) infusions of oxytocin in the same manner (except for safety reasons an adjustment at the highest level after review of the first 7 study participants as indicated in safety plan). In this study healthy people and with those with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will come to the Clinical Research Unit (CRU) and two IVs inserted; one in each forearm. Study participants will have an intravenous infusion of oxytocin at infusion rates that will result in a steady concentration of oxytocin in the blood for 15 minutes. The infusion rate will be increased every 15 minutes for a total of 4 targeted levels. Blood (5 millilitres (ml)) will be withdrawn through the IV not being used for infusion at the end of each of these infusion levels 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. The core group at Stanford University will use mathematics to test the accuracy of the infusion to target the blood concentration.
The main purpose of this study is to define the maximum effect oxytocin has on pain from a 5 minute heat probe applied to the skin and to get an estimate for the relationship between the amounts of pain relief at different amounts of oxytocin in the blood. The study team will use a commercially available device (Medoc TSA II) to heat a probe on the skin to 113 degrees Fahrenheit (45 degrees Celsius) for 5 minutes. Study participants will score any pain noted 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. The study team will do this 5 times during the study, once before the infusion and once during each of the 4 levels of infusion. From this the study team will calculate how the amount of oxytocin in the blood affects pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre
| Arm | Type | Receives |
|---|---|---|
| Oxytocin 4 picogram/millilitre | Experimental | Drug: OxytocinOxytocin infused to maintain serum concentration of 4 picogram/millilitre |
| Oxytocin 16 picogram/millilitre | Experimental | Drug: OxytocinOxytocin infused to maintain serum concentration of 16 picogram/millilitre |
| Oxytocin 64 picogram/millilitre | Experimental | Drug: OxytocinOxytocin infused to maintain serum concentration of 64 picogram/millilitre |
| Oxytocin 256 picogram/millilitre | Experimental | Drug: OxytocinOxytocin infused to maintain serum concentration of 256 picogram/millilitre |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
- 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.
- 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.
- 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)
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- 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
- 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
- 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 infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre | Drug | Oxytocin 16 picogram/millilitre, Oxytocin 256 picogram/millilitre, Oxytocin 4 picogram/millilitre, Oxytocin 64 picogram/millilitre |
Primary outcome
Pharmacodynamics of heat pain after oxytocin
Time frame: Baseline before any infusion 0 minutes
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.
Pharmacodynamics of heat pain oxytocin 16 pg/ml
Time frame: Before Oxytocin infusion 15 minutes after baseline
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.
Pharmacodynamics of heat pain oxytocin 64 pg/ml
Time frame: Before Oxytocin infusion 30 minutes after baseline
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.
Pharmacodynamics of heat pain oxytocin 256 pg/ml
Time frame: Before Oxytocin infusion 45 minutes after baseline
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.
Pharmacodynamics of heat pain oxytocin 4pg/ml
Time frame: After Oxytocin infusion 14 minutes after baseline
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.
Pharmacodynamics of heat pain oxytocin 16 pg/ml
Time frame: After Oxytocin infusion 29 minutes after baseline
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.
Pharmacodynamics of heat pain oxytocin 64pg/ml
Time frame: After Oxytocin infusion 44 minutes after baseline
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.
Pharmacodynamics of heat pain oxytocin 256 pg/ml
Time frame: After Oxytocin infusion 59 minutes after baseline
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.
4 secondary outcomes
Pharmacokinetics of oxytocin in serum 4pg/ml
Time frame: After Oxytocin infusion 15 minutes after baseline
Pharmacokinetics of oxytocin in serum 16 pg/ml
Time frame: After Oxytocin infusion 30 minutes after baseline
Pharmacokinetics of oxytocin in serum 64pg/ml
Time frame: After Oxytocin infusion 45 minutes after baseline
Pharmacokinetics of oxytocin in serum 256pg/ml
Time frame: After Oxytocin infusion 60 minutes after baseline
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 30 Dec 2022.
- 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
1 site in 1 country: see every site and its status.
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 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 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 30 Dec 2022. 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.
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?
Pharmacodynamics of heat pain after oxytocin (time frame: Baseline before any infusion 0 minutes). The study lists 8 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 30 Dec 2022.