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NCT04104646 · ClinicalTrials.gov registry record · Phase 2
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT04104646 is a Phase 2 study that was terminated before completion, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 7 participants.
The verdict
NCT04104646, a Phase 2 study, was terminated before completion, sponsored by Chiesi Farmaceutici S.p.A..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
Interventions
- DRUG Morphine
- DRUG CHF6563
- DRUG CHF6563 matched placebo
- DRUG Morphine matched placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2021-12-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04104646
The ClinicalTrials.gov registry entry for NCT04104646 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chiesi Farmaceutici S.p.A., which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Morphine is the first listed.
NCT04104646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04104646 about?
NCT04104646 is a clinical study titled "CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome". A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
What is the current status of trial NCT04104646?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2020-12-18. Estimated completion is 2021-12-13.
What interventions are being tested in trial NCT04104646?
The interventions under investigation include: Morphine (DRUG), CHF6563 (DRUG), CHF6563 matched placebo (DRUG), Morphine matched placebo (DRUG).
Who is sponsoring clinical trial NCT04104646?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
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