Trial Outcomes & Findings for Efficacy of Spinal Oxytocin in Healthy Volunteers (NCT NCT01996605)
NCT ID: NCT01996605
Last Updated: 2023-09-14
Results Overview
The area of hyperalgesia after the first skin heating following topical capsaicin.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
105 minutes after study drug injection
Results posted on
2023-09-14
Participant Flow
Subjects were recruited from Jan 2, 2014 to Oct 9, 2018 within Wake Forest University Health Sciences (WFUHS) and the community using IRB-approved advertisements. Screening for eligibility and informed consent was obtained at the Pain Mechanisms Laboratory Clinical Research Unit of WFUHS.
Participant milestones
| Measure |
Oxytocin 15 mcg
Oxytocin 15 mcg injected spinally
Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally
|
Oxytocin 150 mcg
Oxytocin 150 mcg injected spinally
Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally
|
Placebo
Preservative free normal saline injected spinally
Placebo: placebo will be administered spinally
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
7
|
|
Overall Study
COMPLETED
|
8
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Spinal Oxytocin in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Oxytocin 15 mcg
n=8 Participants
Oxytocin 15 mcg injected spinally
Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally
|
Oxytocin 150 mcg
n=5 Participants
Oxytocin 150 mcg injected spinally
Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally
|
Placebo
n=7 Participants
Preservative free normal saline injected spinally
Placebo: placebo will be administered spinally
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 11 • n=5 Participants
|
35 years
STANDARD_DEVIATION 9 • n=7 Participants
|
38 years
STANDARD_DEVIATION 10 • n=5 Participants
|
36 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Area of hyperalgesia
|
0 square centimeters
STANDARD_DEVIATION 0 • n=5 Participants
|
0 square centimeters
STANDARD_DEVIATION 0 • n=7 Participants
|
0 square centimeters
STANDARD_DEVIATION 0 • n=5 Participants
|
0 square centimeters
STANDARD_DEVIATION 0 • n=4 Participants
|
PRIMARY outcome
Timeframe: 105 minutes after study drug injectionPopulation: Area of hyperalgesia was determined as described in baseline measures 105 min after study drug injection. The sequence of events was study drug injection followed in 30 min by 5 min heating of the skin followed by capsaicin cream application for 30 min, removal of the cream followed in 30 min by 5 min heating of the skin. After this second heating the area of hyperalgesia was measured.
The area of hyperalgesia after the first skin heating following topical capsaicin.
Outcome measures
| Measure |
Oxytocin 15 mcg
n=8 Participants
Oxytocin 15 mcg injected spinally
Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally
|
Oxytocin 150 mcg
n=5 Participants
Oxytocin 150 mcg injected spinally
Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally
|
Placebo
n=7 Participants
Preservative free normal saline injected spinally
Placebo: placebo will be administered spinally
|
|---|---|---|---|
|
Hyperalgesia
|
103 square centimeters
Standard Deviation 55
|
102 square centimeters
Standard Deviation 76
|
75 square centimeters
Standard Deviation 33
|
Adverse Events
Oxytocin 15 mcg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin 150 mcg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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