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NCT03933397 · ClinicalTrials.gov registry record · Phase 3
Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
A Phase 3 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
NCT03933397: Clinical Trial Phase 3 study, sponsored by Duke University.
NCT03933397 is a Phase 3 study that was terminated before completion, run by Duke University. The registered enrollment target is 328 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03933397, a Phase 3 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.
Primary Outcome
Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a
Interventions
- DRUG Hydromorphone
- DRUG Morphine
- OTHER Patient-Specific Protocol
- OTHER Weight-based Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 3 |
Why NCT03933397 stopped before completion
NCT03933397 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which Hydromorphone is the first listed.
NCT03933397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03933397 about?
NCT03933397 is a clinical study titled "Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease". The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency departme...
What is the current status of trial NCT03933397?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2019-08-13. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT03933397?
The interventions under investigation include: Hydromorphone (DRUG), Morphine (DRUG), Patient-Specific Protocol (OTHER), Weight-based Protocol (OTHER).
Who is sponsoring clinical trial NCT03933397?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03933397's enrollment target sits among peer trials
328 1074th of 2000 higher than 926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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