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NCT03598426 · ClinicalTrials.gov registry record · Phase 3
Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity
A Phase 3 study, sponsored by Loma Linda University.
- Completed
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
NCT03598426: Completed Phase 3 study, sponsored by Loma Linda University.
NCT03598426 is a Phase 3 study that has completed, run by Loma Linda University. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598426, a Phase 3 study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
Study Summary
This study is a single center, prospective, randomized, open-label study aimed at determining the most effective means of preventing hypersensitivity reactions in gynecologic oncology patients receiving paclitaxel infusions. The study will therefore provide clinicians with the best ways of preventing paclitaxel hypersensitivity reactions in their patients during treatment. Subjects will be randomized using the block randomization method into one of these three commonly used treatment methods:(1) Conventional method: oral dexamethasone (20 mg), taking 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of histamine-1 (H1), and a histamine-2 (H2)receptor antagonists administered 30 minutes prior to paclitaxel infusion. (2) Short-course method: intravenous dexamethasone (20 mg), administered concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion. (3) Combined method: oral dexamethasone (20 mg), taking 12 hours prior to treatment in addition to intravenous dexamethasone (20 mg), H1 and H2 receptor antagonists administered 30 minutes prior to paclitaxel infusion. The one-way analysis of variance (ANOVA) would be used to determine if there is any significant difference between the different strategies that are used to pre-medicate patients prior to paclitaxel infusion. P-values of less than 0.05 will be considered statistically significant.
Primary Outcome
The number of participants with any-grade paclitaxel-associated hypersensitivity reactions of the short-course group versus the conventional method group during the first paclitaxel infusion.
Interventions
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-08-08 |
| Est. Completion | 2025-01-07 |
| Phase | Phase 3 |
What the finished NCT03598426 record still lists
NCT03598426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexamethasone is the first listed.
NCT03598426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03598426 about?
NCT03598426 is a clinical study titled "Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity". This study is a single center, prospective, randomized, open-label study aimed at determining the most effective means of preventing hypersensitivity reactions in gynecologic oncology patients receiving paclitaxel infusions. The study will therefore provide clinicians with the best ways of preventin...
What is the current status of trial NCT03598426?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2018-08-08. Estimated completion is 2025-01-07.
What interventions are being tested in trial NCT03598426?
The interventions under investigation include: Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT03598426?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03598426's enrollment target sits among peer trials
90 1724th of 2000 higher than 263 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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