Trial Outcomes & Findings for Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain (NCT NCT05179421)
NCT ID: NCT05179421
Last Updated: 2024-03-19
Results Overview
Pain intensity was reported by the subject at the end of the 5 minute heating of the skin to 45 - 47 degrees C, using a verbal pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature was determined for each individual according to pain rating during screening visit. Pain scores obtained at 15, 30, and 45 minutes after the end of each 10 minute infusion were averaged for each individual and analyzed as th
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
45 min after the end of each study drug infusion
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
First Infusion Day Low Dose Oxytocin, Second Infusion Day High Dose Oxytocin
On the first oxytocin study day, participants will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms. On the second study day they will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms.
Low dose oxytocin: 10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms
High dose oxytocin: 10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms
|
First Infusion Day High Dose Oxytocin, Second Infusion Day Low Dose Oxytocin
On the first oxytocin study day, participants will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms. On the second study day they will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms.
Low dose oxytocin: 10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms
High dose oxytocin: 10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms
|
|---|---|---|
|
First Infusion Day
STARTED
|
14
|
11
|
|
First Infusion Day
COMPLETED
|
13
|
11
|
|
First Infusion Day
NOT COMPLETED
|
1
|
0
|
|
At Least 5 Days Between Infusion Studies
STARTED
|
13
|
11
|
|
At Least 5 Days Between Infusion Studies
COMPLETED
|
13
|
11
|
|
At Least 5 Days Between Infusion Studies
NOT COMPLETED
|
0
|
0
|
|
Second Infusion Day
STARTED
|
13
|
11
|
|
Second Infusion Day
COMPLETED
|
13
|
11
|
|
Second Infusion Day
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
First Infusion Day Low Dose Oxytocin, Second Infusion Day High Dose Oxytocin
On the first oxytocin study day, participants will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms. On the second study day they will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms.
Low dose oxytocin: 10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms
High dose oxytocin: 10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms
|
First Infusion Day High Dose Oxytocin, Second Infusion Day Low Dose Oxytocin
On the first oxytocin study day, participants will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms. On the second study day they will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms.
Low dose oxytocin: 10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms
High dose oxytocin: 10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms
|
|---|---|---|
|
First Infusion Day
Adverse Event
|
1
|
0
|
Baseline Characteristics
Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain
Baseline characteristics by cohort
| Measure |
First Infusion Day Low Dose Oxytocin, Second Infusion Day High Dose Oxytocin
n=13 Participants
On the first oxytocin study day, participants will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms. On the second study day they will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms.
Low dose oxytocin: 10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms
High dose oxytocin: 10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms
|
First Infusion Day High Dose Oxytocin, Second Infusion Day Low Dose Oxytocin
n=11 Participants
On the first oxytocin study day, participants will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms. On the second study day they will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms.
Low dose oxytocin: 10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms
High dose oxytocin: 10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 14 • n=5 Participants
|
42 years
STANDARD_DEVIATION 15 • n=7 Participants
|
41 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 45 min after the end of each study drug infusionPain intensity was reported by the subject at the end of the 5 minute heating of the skin to 45 - 47 degrees C, using a verbal pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature was determined for each individual according to pain rating during screening visit. Pain scores obtained at 15, 30, and 45 minutes after the end of each 10 minute infusion were averaged for each individual and analyzed as th
Outcome measures
| Measure |
Placebo
n=24 Participants
10 minute intravenous infusion of saline placebo
|
Oxytocin 0.3 mcg
n=24 Participants
10 minute intravenous infusion of oxytocin, 0.3 mcg
|
Oxytocin 1.3 mcg
n=24 Participants
10 minute intravenous infusion of oxytocin, 1.3 mcg
|
Oxytocin 7.0 mcg
n=24 Participants
10 minute intravenous infusion of oxytocin, 7.0 mcg
|
|---|---|---|---|---|
|
Dose Response of Intravenous Oxytocin on Sustained Heat Pain
Prior to infusion
|
3.1 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.1
|
3.1 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.1
|
|
Dose Response of Intravenous Oxytocin on Sustained Heat Pain
45 minutes after end of infusion
|
2.3 units on a scale
Standard Deviation 1.5
|
2.3 units on a scale
Standard Deviation 1.5
|
2.2 units on a scale
Standard Deviation 1.5
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Dose Response of Intravenous Oxytocin on Sustained Heat Pain
Average of 15, 30, and 45 min scores (Primary Outcome Measure)
|
2.4 units on a scale
Standard Deviation 1.4
|
2.4 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 1.3
|
|
Dose Response of Intravenous Oxytocin on Sustained Heat Pain
15 minutes after end of infusion
|
2.4 units on a scale
Standard Deviation 1.5
|
2.4 units on a scale
Standard Deviation 1.4
|
2.3 units on a scale
Standard Deviation 1.3
|
2.3 units on a scale
Standard Deviation 1.6
|
|
Dose Response of Intravenous Oxytocin on Sustained Heat Pain
30 minutes after end of infusion
|
2.5 units on a scale
Standard Deviation 1.4
|
2.4 units on a scale
Standard Deviation 1.4
|
2.3 units on a scale
Standard Deviation 1.7
|
2.2 units on a scale
Standard Deviation 1.3
|
Adverse Events
Placebo Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin, 0.3 mcg Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin, 1.3 mcg Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin, 7.0 mcg Infusion
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
Professor James C. Eisenach, MD
Wake Forest University School of Medicine
Phone: 336-716-4182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place