Trial Outcomes & Findings for Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin (NCT NCT03935399)
NCT ID: NCT03935399
Last Updated: 2021-04-05
Results Overview
Vibration frequency detection threshold in the burned area after IM Oxytocin or placebo injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
COMPLETED
PHASE4
10 participants
From 5 minutes to 120 minutes
2021-04-05
Participant Flow
Participant milestones
| Measure |
Oxytocin First, Then Saline Placebo
Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
Saline: 1.5 ml preservative free saline for intramuscular injection
|
Saline Placebo First, Then Oxytocin
Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
First Study Day
STARTED
|
5
|
5
|
|
First Study Day
COMPLETED
|
5
|
5
|
|
First Study Day
NOT COMPLETED
|
0
|
0
|
|
Second Study Day
STARTED
|
5
|
5
|
|
Second Study Day
COMPLETED
|
5
|
5
|
|
Second Study Day
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
Baseline characteristics by cohort
| Measure |
Oxytocin First, Then Saline Placebo
n=5 Participants
Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
Saline: 1.5 ml preservative free saline for intramuscular injection
|
Saline Placebo First, Then Oxytocin
n=5 Participants
Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
Saline: 1.5 ml preservative free saline for intramuscular injection
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 12 • n=99 Participants
|
40 years
STANDARD_DEVIATION 12 • n=107 Participants
|
38 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Body Mass Index
|
29 kg/m^2
STANDARD_DEVIATION 5 • n=99 Participants
|
26 kg/m^2
STANDARD_DEVIATION 3 • n=107 Participants
|
27 kg/m^2
STANDARD_DEVIATION 4 • n=206 Participants
|
PRIMARY outcome
Timeframe: From 5 minutes to 120 minutesPopulation: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for vibration FREQUENCY detection threshold and the last 5 participants were tested for vibration INTENSITY detection threshold. This outcome relates to the first 5 participants only.
Vibration frequency detection threshold in the burned area after IM Oxytocin or placebo injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
Outcome measures
| Measure |
Oxytocin
n=5 Participants
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
|
Placebo
n=5 Participants
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection
|
22 Hz
Standard Deviation 14
|
21 Hz
Standard Deviation 8
|
PRIMARY outcome
Timeframe: From 5 minutes to 120 minutesPopulation: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain THRESHOLD to mechanical stimulation and the last 5 participants were tested for degree of pain INTENSITY to a fixed mechanical stimulation. This outcome relates to the first 5 participants only.
Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin or Placebo injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
Outcome measures
| Measure |
Oxytocin
n=5 Participants
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
|
Placebo
n=5 Participants
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection.
|
0.20 grams
Standard Deviation 0.66
|
0.29 grams
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: From 5 minutes to 65 minutesPopulation: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain THRESHOLD to mechanical stimulation and the last 5 participants were tested for degree of pain INTENSITY to a fixed mechanical stimulation. This outcome relates to the last 5 participants only.
Hypersensitivity in the burned area after IM Oxytocin or placebo injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared.
Outcome measures
| Measure |
Oxytocin
n=5 Participants
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
|
Placebo
n=5 Participants
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection.
|
6.4 cm^2
Standard Deviation 8.6
|
8.8 cm^2
Standard Deviation 8.6
|
PRIMARY outcome
Timeframe: From 5 minutes to 65 minutesPopulation: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for vibration FREQUENCY detection threshold and the last 5 participants were tested for vibration INTENSITY detection threshold. This outcome relates to the last 5 participants only.
Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin or placebo injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz.
Outcome measures
| Measure |
Oxytocin
n=5 Participants
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
|
Placebo
n=5 Participants
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection
|
1.8 Hz
Standard Deviation 1.4
|
1.7 Hz
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: From 21 minutes to 125 minutesPopulation: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain report to sustained heat applied to the ARM and the last 5 participants were tested for pain report to sustained heat applied to the LEG. This outcome relates to the first 5 participants only.
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin or placebo injection.
Outcome measures
| Measure |
Oxytocin
n=5 Participants
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
|
Placebo
n=5 Participants
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
Change in Sustained Heat After IM Injection Non Dominant Arm
|
-0.30 units on a scale
Standard Deviation 0.65
|
-0.70 units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: From 36 minutes to 40 minutesPopulation: Please note that the protocol was amended after the first 5 participants. Only the last 5 participants were tested for pain report to sustain heat applied at the site of the UV-B burn.
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin or placebo injection.
Outcome measures
| Measure |
Oxytocin
n=5 Participants
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
|
Placebo
n=5 Participants
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
Change in Sustained Heat After IM Injection
|
0.10 score on a scale
Standard Deviation 0.22
|
-0.20 score on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: From 21 minutes to 65 minutesPopulation: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain report to sustained heat applied to the ARM and the last 5 participants were tested for pain report to sustained heat applied to the LEG. This outcome relates to the last 5 participants only.
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin or placebo injection.
Outcome measures
| Measure |
Oxytocin
n=5 Participants
Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
|
Placebo
n=5 Participants
Saline: 1.5 ml preservative free saline for intramuscular injection
|
|---|---|---|
|
Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg)
|
-0.55 score on a scale
Standard Deviation 0.94
|
0.10 score on a scale
Standard Deviation 0.55
|
Adverse Events
Oxytocin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place