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NCT04749628 · ClinicalTrials.gov registry record · Phase 4
Cannabidiol for Bilateral Total Knee Arthroplasty
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT04749628 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 37 participants.
The verdict
NCT04749628, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. Epidiolex®, an oral cannabidiol (CBD) solution, is the first ever cannabis-derived medication to be approved by the Food \& Drug Administration. Our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg Epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (BTKA). We will be estimating whether Epidiolex® is associated with minimal opioid use and adequate analgesia. We will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.
Interventions
- DRUG cannabidiol
- OTHER Ora-sweet SF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2025-01-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04749628
The ClinicalTrials.gov registry entry for NCT04749628 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which cannabidiol is the first listed.
NCT04749628 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04749628 about?
NCT04749628 is a clinical study titled "Cannabidiol for Bilateral Total Knee Arthroplasty". In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient pop...
What is the current status of trial NCT04749628?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2022-11-02. Estimated completion is 2025-01-08.
What interventions are being tested in trial NCT04749628?
The interventions under investigation include: cannabidiol (DRUG), Ora-sweet SF (OTHER).
Who is sponsoring clinical trial NCT04749628?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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