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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.

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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

FieldValue
Enrollment Target 7 participants
Start Date 2020-12-18
Est. Completion 2021-12-13
Phase Phase 2

Sponsor

Chiesi Farmaceutici S.p.A.

30 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.