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NCT04562597 · ClinicalTrials.gov registry record · Phase 1
A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.
A Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT04562597 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 50 participants.
The verdict
NCT04562597, a Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.
Interventions
- DRUG Dose Response Curve Placebo
- DRUG Dose Response Curve N-acetylcysteine 50 mg/kg
- DRUG Dose Response Curve N-acetylcysteine 100 mg/kg
- DRUG Dose Response Curve N-acetylcysteine 150 mg/kg
- DRUG Opioid Reduction with Optimal N-acetylcysteine Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2022-05-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04562597
The ClinicalTrials.gov registry entry for NCT04562597 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dose Response Curve Placebo is the first listed.
NCT04562597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04562597 about?
NCT04562597 is a clinical study titled "A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.". Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.
What is the current status of trial NCT04562597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2021-01-20. Estimated completion is 2022-05-21.
What interventions are being tested in trial NCT04562597?
The interventions under investigation include: Dose Response Curve Placebo (DRUG), Dose Response Curve N-acetylcysteine 50 mg/kg (DRUG), Dose Response Curve N-acetylcysteine 100 mg/kg (DRUG), Dose Response Curve N-acetylcysteine 150 mg/kg (DRUG), Opioid Reduction with Optimal N-acetylcysteine Dose (DRUG).
Who is sponsoring clinical trial NCT04562597?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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