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Hormone Therapy

Oxytocin for Knee Osteoarthritis

Phase 2
Recruiting
Led By James C Eisenach, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 65 minutes after the beginning of the oxytocin infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying oxytocin to see if it can reduce pain in people with severe knee arthritis.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include reactions at the infusion site, changes in blood pressure or heart rate due to oxytocin's known effects on smooth muscle tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~65 minutes after the beginning of the oxytocin infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 65 minutes after the beginning of the oxytocin infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxytocin

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OxytocinExperimental Treatment1 Intervention
Oxytocin administered by IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,297 Total Patients Enrolled
10 Trials studying Osteoarthritis
924 Patients Enrolled for Osteoarthritis
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
768 Total Patients Enrolled
1 Trials studying Osteoarthritis
80 Patients Enrolled for Osteoarthritis

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04431206 — Phase 2
Osteoarthritis Research Study Groups: Oxytocin
Osteoarthritis Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT04431206 — Phase 2
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04431206 — Phase 2
~1 spots leftby Feb 2025
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