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NCT02344225 · ClinicalTrials.gov registry record · Phase 2
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
A Phase 2 study, sponsored by State University of New York - Downstate Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02344225 is a Phase 2 study that has completed, run by State University of New York - Downstate Medical Center. The registered enrollment target is 14 participants.
The verdict
NCT02344225, a Phase 2 study, has completed, sponsored by State University of New York - Downstate Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.
Interventions
- DRUG Ketorolac
- DRUG Ibuprofen
- DRUG Caffeine citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-01-01 |
| Est. Completion | 2018-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02344225
The ClinicalTrials.gov registry entry for NCT02344225 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Downstate Medical Center, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ketorolac is the first listed.
NCT02344225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02344225 about?
NCT02344225 is a clinical study titled "Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)". Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stage...
What is the current status of trial NCT02344225?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2015-01-01. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT02344225?
The interventions under investigation include: Ketorolac (DRUG), Ibuprofen (DRUG), Caffeine citrate (DRUG).
Who is sponsoring clinical trial NCT02344225?
This trial is sponsored by State University of New York - Downstate Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
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