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NCT05179421 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT05179421: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT05179421 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05179421, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This is a study of participants that will receive intravenous (IV) infusions of oxytocin (naturally occurring hormone that is made by the brain). In this study healthy participants will be recruited for the study. There will be 3 study related visits: 1) screening and informed consent 2) study medication infusions and thermal heat testing 3) study medication infusions and thermal heat testing. During study visits 2 and 3 an IV catheter will be placed and a dose of oxytocin or placebo (inactive solution) will be given over a 10 minute period; 1 hour after the first infusion, a second 10 minute infusion of oxytocin will be administered. Investigators will perform some tests to evaluate how oxytocin changes perceptions of the skin. Investigators will study a painful perception by placing a probe on the skin of the side of lower leg and heating it up to 113-117 degrees Fahrenheit (F) (45-47 degrees Celsius (C)) for 5 minutes. Each participant will score any pain that is experienced on a 0 to 10 scale for each minute during the heating period. Most people find that pain rises during the 5 minutes, but remains mild; usually less than 5 on the 0 to 10 pain scale. The temperature of the 5 minute heating will be determined according to the participants pain rating during the screening visit. The primary objective of the study is to determine the dose response of IV oxytocin for analgesia (pain relief) to experimental heat pain.
Primary Outcome
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
Interventions
- DRUG Low dose oxytocin
- DRUG High dose oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2023-02-10 |
| Phase | Phase 2 |
What the finished NCT05179421 record still lists
NCT05179421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Low dose oxytocin is the first listed.
NCT05179421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05179421 about?
NCT05179421 is a clinical study titled "Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain". This is a study of participants that will receive intravenous (IV) infusions of oxytocin (naturally occurring hormone that is made by the brain). In this study healthy participants will be recruited for the study. There will be 3 study related visits: 1) screening and informed consent 2) study medi...
What is the current status of trial NCT05179421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2022-05-09. Estimated completion is 2023-02-10.
What interventions are being tested in trial NCT05179421?
The interventions under investigation include: Low dose oxytocin (DRUG), High dose oxytocin (DRUG).
Who is sponsoring clinical trial NCT05179421?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05179421's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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