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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 is a Phase 1 study that has completed, run by Syntrix Biosystems. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03312777
The ClinicalTrials.gov registry entry for NCT03312777 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syntrix Biosystems, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03312777 reports 0 study locations.
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.
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