Osteoarthritis, KneePhase 2NCT04427540
Oxytocin Pharmacokinetics After Intramuscular Injection
A Phase 2 study testing Oxytocin in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences.
Trial summary
In this study people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will have an intravenous catheter (IV) inserted in the forearm. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- Dec 2021to Dec 2022
- 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
- No healthy volunteers
- 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. 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.
- 5. diagnosis of advanced knee arthritis
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
In this study people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will have an intravenous catheter (IV) inserted in the forearm. A single intramuscular (IM) injection of oxytocin (Pitocin®), 17 micrograms will be administered and blood samples will be taken several times over the next 120 minutes. The amount of oxytocin will be measured in the blood samples.
The main purpose of this study is to sample the blood, before and after the administration of oxytocin and calculate the pharmacokinetics (amount of oxytocin in the blood over time) of oxytocin.
Read the detailed description
This is an unblinded, sequential study of subjects, all will receive an intramuscular (IM) injection 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 people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Participants will come to the Clinical Research Unit (CRU) and have an intravenous catheter (IV) inserted in the forearm. Participants will get a single IM injection of oxytocin (Pitocin®), 17 micrograms (10 International Units (IU)) 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. The Core group at Stanford will use mathematics 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. 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
- 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 10 micrograms IM
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Single IM injection Oxytocin 17 micrograms Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin concentration in serum
Amount of Oxytocin in serum measured in picograms/millilitres (pg/ml) after IM Oxytocin administered
Measured: 1 minute post administration to 120 minutes post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Study was not initiated; no subjects were consented or enrolled
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
- Single IM injection of Oxytocin 17 micrograms
- 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
- NCT04427540
- Sponsor's protocol ID
- IRB00065842
- Status last verified
- Apr 2021
- First submitted
- 5 Jun 2020
- Last updated
- 12 Apr 2021
- 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 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Pharmacokinetics After Intramuscular Injection
- ClinicalTrials.gov ID
- NCT04427540
- Acronym / sponsor ID
- IRB00065842
- Conditions
- Osteoarthritis, Knee
- Keywords
- advanced knee arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated; no subjects were consented or enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 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.
In this study people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will have an intravenous catheter (IV) inserted in the forearm. A single intramuscular (IM) injection of oxytocin (Pitocin®), 17 micrograms will be administered and blood samples will be taken several times over the next 120 minutes. The amount of oxytocin will be measured in the blood samples.
The main purpose of this study is to sample the blood, before and after the administration of oxytocin and calculate the pharmacokinetics (amount of oxytocin in the blood over time) of oxytocin.
Detailed description
This is an unblinded, sequential study of subjects, all will receive an intramuscular (IM) injection 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 people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Participants will come to the Clinical Research Unit (CRU) and have an intravenous catheter (IV) inserted in the forearm. Participants will get a single IM injection of oxytocin (Pitocin®), 17 micrograms (10 International Units (IU)) 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. The Core group at Stanford will use mathematics 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. 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
- Single IM injection of Oxytocin 17 micrograms
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinSingle IM injection Oxytocin 17 micrograms |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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. 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.
- 5. diagnosis of advanced knee arthritis
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 10 micrograms IM | Drug | Oxytocin |
Primary outcome
Oxytocin concentration in serum
Time frame: 1 minute post administration to 120 minutes post administration
Amount of Oxytocin in serum measured in picograms/millilitres (pg/ml) after IM Oxytocin administered
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 Apr 2021.
- 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 5 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 Apr 2021. 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?
Oxytocin concentration in serum (time frame: 1 minute post administration to 120 minutes post administration). 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 Apr 2021.