Trial Outcomes & Findings for Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects (NCT NCT04431206)
NCT ID: NCT04431206
Last Updated: 2025-09-11
Results Overview
Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature is determined by pain rating during screening visit.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
2-10 minutes after starting oxytocin infusion, depending on Arm
Results posted on
2025-09-11
Participant Flow
Healthy participants were recruited from the community from October 15, 2020 through November 15, 2020 via IRB-approved advertisements and IRB-approved lists of previous participants who agreed to be contacted for future studies. They were recruited by phone and provided written informed consent at the day of the training visit.
Participant milestones
| Measure |
Verbal Pain Score at 2 Minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 5 Minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 7 Minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 10 Minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects
Baseline characteristics by cohort
| Measure |
Verbal Pain Score at 2 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 5 Minutes
n=1 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 7 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 10 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
34 years
n=7 Participants
|
22.5 years
n=5 Participants
|
25 years
n=4 Participants
|
26 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Verbal pain score at the end of 5 minute skin heating
|
3.0 units on a scale
n=5 Participants
|
5.0 units on a scale
n=7 Participants
|
3.5 units on a scale
n=5 Participants
|
2.0 units on a scale
n=4 Participants
|
3.1 units on a scale
n=21 Participants
|
PRIMARY outcome
Timeframe: 2-10 minutes after starting oxytocin infusion, depending on ArmPain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature is determined by pain rating during screening visit.
Outcome measures
| Measure |
Verbal Pain Score at 2 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 5 Minutes
n=1 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 7 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 10 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
|---|---|---|---|---|
|
First Verbal Pain Score After Beginning IV Oxytocin Infusion
|
3.5 units on a scale
Interval 3.0 to 4.0
|
4.0 units on a scale
Interval 4.0 to 4.0
|
3.5 units on a scale
Interval 3.0 to 4.0
|
1.5 units on a scale
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: 17-25 minutes after starting oxytocin infusion, depending on ArmPain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature is determined by pain rating during screening visit.
Outcome measures
| Measure |
Verbal Pain Score at 2 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 5 Minutes
n=1 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 7 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 10 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
|---|---|---|---|---|
|
Second Verbal Pain Score After Beginning IV Oxytocin Infusion
|
1.5 units on a scale
Interval 1.0 to 2.0
|
3.0 units on a scale
Interval 3.0 to 3.0
|
1.5 units on a scale
Interval 1.0 to 2.0
|
1.0 units on a scale
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: 32-40 minutes after starting oxytocin infusion, depending on ArmPain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature is determined by pain rating during screening visit.
Outcome measures
| Measure |
Verbal Pain Score at 2 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 5 Minutes
n=1 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 7 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 10 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
|---|---|---|---|---|
|
Third Verbal Pain Score After Beginning IV Oxytocin Infusion
|
3.0 units on a scale
Interval 3.0 to 3.0
|
4.0 units on a scale
Interval 4.0 to 4.0
|
1.0 units on a scale
Interval 1.0 to 1.0
|
1.0 units on a scale
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: 47-55 minutes after starting oxytocin infusion, depending on ArmPain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature is determined by pain rating during screening visit.
Outcome measures
| Measure |
Verbal Pain Score at 2 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 5 Minutes
n=1 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 7 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 10 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
|---|---|---|---|---|
|
Fourth Verbal Pain Score After Beginning IV Oxytocin Infusion
|
2.0 units on a scale
Interval 1.0 to 3.0
|
3.0 units on a scale
Interval 3.0 to 3.0
|
2.0 units on a scale
Interval 1.0 to 3.0
|
1.0 units on a scale
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: 62-70 minutes after starting oxytocin infusion, depending on ArmPain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature is determined by pain rating during screening visit.
Outcome measures
| Measure |
Verbal Pain Score at 2 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 5 Minutes
n=1 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 7 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
Verbal Pain Score at 10 Minutes
n=2 Participants
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes
Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0
|
|---|---|---|---|---|
|
Fifth Verbal Pain Score After Beginning IV Oxytocin Infusion
|
3.0 units on a scale
Interval 3.0 to 3.0
|
2.0 units on a scale
Interval 2.0 to 2.0
|
1.5 units on a scale
Interval 1.0 to 2.0
|
0.5 units on a scale
Interval 0.0 to 1.0
|
Adverse Events
Verbal Pain Score at 2 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Verbal Pain Score at 5 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Verbal Pain Score at 7 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Verbal Pain Score at 10 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Eisenach
Wake Forest University School of Medicine
Phone: 3367164182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place