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NCT03312777 · ClinicalTrials.gov registry record · Phase 1
Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers
A Phase 1 study, sponsored by Syntrix Biosystems.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03312777: Completed Phase 1 study, sponsored by Syntrix Biosystems.
NCT03312777 is a Phase 1 study that has completed, run by Syntrix Biosystems. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03312777, a Phase 1 study, has completed, sponsored by Syntrix Biosystems.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and during treatment with Omnitram, tramadol, and placebo.
Primary Outcome
The participant immerses a hand in cold water for a maximum of 3 minutes and reports the pain they experience using a "0 (no pain) to 10 (worst pain)" scale. Immersion of hand in ice cold water
Interventions
- DRUG Placebo
- DRUG Tramadol
- DRUG Omnitram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2017-12-22 |
| Phase | Phase 1 |
What the finished NCT03312777 record still lists
NCT03312777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03312777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03312777 about?
NCT03312777 is a clinical study titled "Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers". This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and during treatment with Omnitram,...
What is the current status of trial NCT03312777?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-10-31. Estimated completion is 2017-12-22.
What interventions are being tested in trial NCT03312777?
The interventions under investigation include: Placebo (DRUG), Tramadol (DRUG), Omnitram (DRUG).
Who is sponsoring clinical trial NCT03312777?
This trial is sponsored by Syntrix Biosystems, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03312777's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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