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CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

NCT04104646 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-08-03

Study results available
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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

Conditions

  • Neonatal Opioid Withdrawal Syndrome

Interventions

DRUG

CHF6563

Sublingual CHF6563 administration at starting dose of 10 µg/kg q8

DRUG

Morphine

Oral morphine administration at starting dose of 0.07 mg/kg q4

DRUG

CHF6563 matched placebo

Sublingual CHF6563 matched placebo administration

DRUG

Morphine matched placebo

Oral morphine matched placebo administration

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Walter Kraft · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2021-12-13
Completion
2021-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104646 on ClinicalTrials.gov