Overseen ByJames C Eisenach, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Wake Forest University Health Sciences
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain).
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 an IV catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion. Investigators will perform some tests to evaluate how oxytocin changes perceptions on the skin. Investigators will study a painful perception by placing a probe on the skin and heating it to 113 -117 degrees Fahrenheit (F) 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. The 5 minute heating temperature will be determined according to the subjects pain rating during the screening visit.
The main goal of the study is to determine the effect of oxytocin during and after a fixed rate intravenous infusion on reduction in pain to a sustained heat stimulus in order to generate a model for peripheral analgesia.
What safety data exists for oxytocin treatment?Oxytocin, including its synthetic forms like Syntocinon, has been widely used in obstetrics, particularly for labor induction and postpartum hemorrhage control. Safety data indicates that while it is generally effective, there are potential risks. No side effects were observed in a study with 3,342 obstetrical patients using Syntocinon, but there are reports of allergic reactions and adverse effects such as nausea, vomiting, hypertension, and coronary artery spasm. Misuse can lead to serious problems for both mother and fetus, including arrhythmias, uterine hyperstimulation, and fetal distress. Continuous monitoring and proper dosage adjustment are crucial to minimize risks.13456
What data supports the idea that Oxytocin for Knee Osteoarthritis is an effective treatment?The available research shows that oxytocin might have potential benefits for knee osteoarthritis. It is involved in bone health and may help with bone formation and reducing inflammation, which are important in osteoarthritis. Oxytocin is also linked to pain relief, which could be beneficial for people with this condition. However, the research mainly discusses its effects on bone health and pain in general, rather than specific studies on knee osteoarthritis. Therefore, while there is some support for its potential use, more direct research is needed to confirm its effectiveness for knee osteoarthritis specifically.234810
Do I have to stop taking my current medications for the trial?The trial does not specify if you must stop all current medications, but you cannot participate if you take benzodiazepines, pain medications daily, or certain other drugs like thiazide diuretics, SSRIs, or MAOIs. Check with the trial team for more details.
Is the drug Oxytocin a promising treatment for knee osteoarthritis?Yes, Oxytocin shows promise as a treatment for knee osteoarthritis. It may help with bone health and cartilage formation, which are important for joint function. It also has potential pain-relieving effects, making it a promising option for managing osteoarthritis symptoms.378910
Eligibility Criteria
This trial is for adults aged 18-75 with a BMI under 40, either healthy or suffering from severe knee arthritis. Healthy participants must have normal blood pressure and heart rate without medication; those with arthritis can be on blood pressure meds. Women of childbearing age should use effective birth control.Participant Groups
The study tests the pain-reducing effects of oxytocin, given through an IV, in response to sustained heat applied to the skin. Participants will rate their pain during this process to help develop a model for peripheral analgesia using oxytocin.
1Treatment groups
Experimental Treatment
Group I: OxytocinExperimental Treatment1 Intervention
Oxytocin administered by IV infusion
Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Pitocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇪🇺 Approved in European Union as Syntocinon for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇨🇦 Approved in Canada as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇦🇺 Approved in Australia as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Wake Forest Baptist HealthWinston-Salem, NC
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
References
Anaphylactoid reaction to oxytocin in pregnancy. [2019]A case of an allergic reaction to Syntocinon (synthetic oxytocin) administered during Caesarean section is reported.
Randomised controlled trial of oxytocin alone versus oxytocin and ergometrine in active management of third stage of labour. [2019]To compare intramuscular oxytocin alone and intramuscular oxytocin with ergometrine (Syntometrine) for their effect in reducing the risk of postpartum haemorrhage when both are used as part of the active management of the third stage of labour.
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]Oxytocin (Syntocinon, Sandoz Pharmaceuticals) is a commonly used drug in the modern management of labour. A recently published British survey found that 38% of low risk primigravid labours were augmented, most commonly by intravenous syntocinon. Unfortunately the misuse of syntocinon can lead to potentially serious problems for the fetus and mother. Despite the frequency of usage there appears to be no consensus as to the optimal dose and mode of administration. This paper explores the extent of this variation among Scottish obstetric units, the reasons for any variation in its use and makes some suggestions as to the way forward based on the current literature.
A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. [2021]Syntometrine is an effective uterotonic agent used in preventing primary postpartum haemorrhage but has adverse effects including nausea, vomiting, hypertension and coronary artery spasm. Carbetocin is a newly developed long-acting oxytocin analogue that might be used as an uterotonic agent. We compare the efficacy and safety of intramuscular (IM) carbetocin with IM syntometrine in preventing primary postpartum haemorrhage.
Aggregate analysis of oxytocin incidents. [2016]Oxytocin is a valuable, time-tested drug and one of the most commonly used medications during labour and delivery.It acts on the smooth muscle of the uterus to stimulate contractions. In Canada, its uses include the induction of labour in patients with a medical indication for the initiation of labour; the stimulation and reinforcement of labour; and to control postpartum bleeding and hemorrhage.' As a high-alert medication, oxytocin bears a heightened risk of causing significant patient harm if used in error. For example, use of this drug to induce labour has been associated with significant adverse effects to both the mother (e.g., arrhythmias, uterine hyperstimulation, postpartum hemorrhage) and the fetus (e.g., bradycardia, hypoxia, hyperbilirubinemia, retinal hemorrhage).This bulletin shares information about incidents involving the use of oxytocin that have been voluntarily reported to the Canadian Medication Incident Reporting and Prevention System (CMIRPS). It includes an overview of the incidents and highlights major themes identified through a multi-incident analysis to raise awareness about continuous improvement opportunities for management of this medication.
Oxytocin Controls Chondrogenesis and Correlates with Osteoarthritis. [2021]This study investigated the relationship of oxytocin (OT) to chondrogenesis and osteoarthritis (OA). Human bone marrow and multipotent adipose-derived stem cells were cultured in vitro in the absence or presence of OT and assayed for mRNA transcript expression along with histological and immunohistochemical analyses. To study the effects of OT in OA in vivo, a rat model and a human cohort of 63 men and 19 women with hand OA and healthy controls, respectively, were used. The baseline circulating OT, interleukin-6, leptin, and oestradiol levels were measured, and hand X-ray examinations were performed for each subject. OT induced increased aggrecan, collagen (Col) X, and cartilage oligomeric matrix protein mRNA transcript levels in vitro, and the immunolabelling experiments revealed a normalization of Sox9 and Col II protein expression levels. No histological differences in lesion severity were observed between rat OA groups. In the clinical study, a multivariate analysis adjusted for age, body mass index, and leptin levels revealed a significant association between OA and lower levels of OT (odds ratio = 0.77; p = 0.012). Serum OT levels are reduced in patients with hand OA, and OT showed a stimulatory effect on chondrogenesis. Thus, OT may contribute to the pathophysiology of OA.
Protective Effect of Oxytocin Against Bone Loss in a Female Rat Model of Osteoporosis. [2022]Introduction: Oxytocin (OT) has been proposed to assist in the regulation of bone remodeling and to exert an antiosteoporotic effect. We evaluated the possible protective effect of OT against bone degeneration in ovariectomized (OVX) rats.
Evaluating the efficacy of intranasal oxytocin on pain and function among individuals who experience chronic pain: a protocol for a multisite, placebo-controlled, blinded, sequential, within-subjects crossover trial. [2022]Current treatments for chronic pain (eg, opioids) can have adverse side effects and rarely result in resolution of pain. As such, there is a need for adjuvant analgesics that are non-addictive, have few adverse side effects and are effective for pain management across several chronic pain conditions. Oxytocin is a naturally occurring hormone that has gained attention for its potential analgesic properties. The objective of this trial is to evaluate the efficacy of intranasal oxytocin on pain and function among adults with chronic pain.
Relationship between Oxytocin and Osteoarthritis: Hope or Despair? [2021]Oxytocin (OT) is involved in breastfeeding and childbirth and appears to play a role in regulating the bone matrix. OT is synthesized in the supraoptic and paraventricular nuclei of the hypothalamus and is released in response to numerous stimuli. It also appears to be produced by osteoblasts in the bone marrow, acting as a paracrine-autocrine regulator of bone formation. Osteoarthritis (OA) is a disease of the whole joint. Different tissues involved in OA express OT receptors (OTRs), such as chondrocytes and osteoblasts. This hormone, which levels are reduced in patients with OA, appears to have a stimulatory effect on chondrogenesis. OT involvement in bone biology could occur at both the osteoblast and chondrocyte levels. The relationships between metabolic syndrome, body weight, and OA are well documented, and the possible effects of OT on different parameters of metabolic syndrome, such as diabetes and body weight, are important. In addition, the effects of OT on adipokines and inflammation are also discussed, especially since recent data have shown that low-grade inflammation is also associated with OA. Furthermore, OT also appears to mediate endogenous analgesia in animal and human studies. These observations provide support for the possible interest of OT in OA and its potential therapeutic treatment.