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NCT03878589 · ClinicalTrials.gov registry record · Phase 2
Understanding Cognition, Oxytocin & Pain in Elders
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT03878589: Completed Phase 2 study, sponsored by University of Florida.
NCT03878589 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878589, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
Osteoarthritis (OA) represents a significant cause of disability worldwide and the knee is the most commonly affected joint. Oxytocin (OT) is a mediator of endogenous analgesia in animal and human studies. This proposal will test the efficacy and safety of self-administered intranasal OT over 4-weeks in older individuals relative to placebo (P) evaluating its effects on pain and function in aging and testing potential underlying neurobiological mechanisms.
Primary Outcome
The WOMAC Pain subscale measures self-reported knee pain severity during daily activities. The subscale consists of 5 items assessing pain during walking, stair climbing, nocturnal pain, pain at rest, and weight-bearing activities. Each item is scored 0-4 (0=none, 4=extreme), yielding a total Pain subscale score of 0-20. Higher scores indicate greater pain severity. Change scores were calculated as post-treatment minus baseline; negative values indicate improvement (reduced pain).
Interventions
- DRUG Placebo (P)
- DRUG Oxytocin (OT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2019-08-06 |
| Est. Completion | 2024-12-19 |
| Phase | Phase 2 |
What the finished NCT03878589 record still lists
NCT03878589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (P) is the first listed.
NCT03878589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03878589 about?
NCT03878589 is a clinical study titled "Understanding Cognition, Oxytocin & Pain in Elders". Osteoarthritis (OA) represents a significant cause of disability worldwide and the knee is the most commonly affected joint. Oxytocin (OT) is a mediator of endogenous analgesia in animal and human studies. This proposal will test the efficacy and safety of self-administered intranasal OT over 4-week...
What is the current status of trial NCT03878589?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2019-08-06. Estimated completion is 2024-12-19.
What interventions are being tested in trial NCT03878589?
The interventions under investigation include: Placebo (P) (DRUG), Oxytocin (OT) (DRUG).
Who is sponsoring clinical trial NCT03878589?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03878589's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 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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