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Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

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ClinicalTrials.gov Identifier: NCT04435704
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE June 4, 2020
First Posted Date  ICMJE June 17, 2020
Last Update Posted Date October 22, 2020
Estimated Study Start Date  ICMJE January 2022
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: Baseline at time of infusion ]
    Prior to the initiation of the oxytocin infusion, the skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: 9 minutes after baseline ]
    10% dose escalation. The skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: 24 minutes after baseline ]
    30% dose escalation. The skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: 54 minutes after baseline ]
    70% dose escalation. The skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: 69 minutes after baseline ]
    90% dose escalation. The skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: 84 minutes after baseline ]
    70% dose de-escalation. The skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: 99 minutes after baseline ]
    30% dose de-escalation. The skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
  • Verbal pain after heating the skin to 45 degrees Celsius [ Time Frame: 114 minutes after baseline ]
    10% dose de-escalation. The skin will be heated to 45 degrees Celsius for 5 minutes and pain 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects
Official Title  ICMJE Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects
Brief Summary

The goal of this study is to validate the pharmacodynamic model for pain relief from oxytocin at a peripheral site by intravenous infusion targeted at different levels of the drug.

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 intravenous(IV) catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion in varying amounts. The study team will perform some tests to evaluate how oxytocin changes perceptions on the skin. 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 Pharmacokinetic/Pharmacodynamic (PK/PD) study in which oxytocin is infused in increasing steps to different levels up and down in a set manner and the PD effect of pain relief from each level of oxytocin determined. All study participants will receive the same treatment and will not be blinded to the experimental plan, although particpants will not be informed when oxytocin levels are changing.

In this study healthy people or those 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 one intravenous catheter (IV) will be inserted in the forearm for oxytocin infusion. In this study, the oxytocin rate will be changed every 15 minutes for 7 times. Oxytocin will be infused by IV route and 5-min heat pain tests obtained, but instead of giving oxytocin at a constant rate, the rate will be adjusted every 15 minutes to aim to get the right amount at the effect site to reduce pain by 10% of the maximum, then 30%, then 70%, then 90%, then back down to 70%, 30%, and 10%. At the end of each of these 7 15-min infusions participants will be tested for pain with heat and the study team will compare how effective the calculations for the effect site are to control the amount of pain relief obtained at each level.

This information will be analyzed by another group at Stanford University in the PK/PD Core part of this application. Mathematics will be used to calculate how quickly oxytocin moves from the blood to where it reduces pain (Part 1) and to test the accuracy of these calculations (Part 2).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Oxytocin will be administered by intravenous infusion at increasing and decreasing rates
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Drug: Oxytocin
Intravenous Oxytocin
Other Name: Pitocin
Study Arms  ICMJE Experimental: Oxytocin
Oxytocin will be administered at increasing and decreasing rates
Intervention: Drug: Oxytocin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Regina Curry, RN 336-716-4294 RECURRY@WAKEHEALTH.EDU
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04435704
Other Study ID Numbers  ICMJE IRB00066138
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James C Eisenach, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP