Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Duration of treatment defined as the number of hours from first dose of study drug administration until the last dose of study drug. Shown are results for the duration of treatment in all treated patients, regardless of discontinuation status, as well as those patients who completed the study (with non missing data). The number of subjects randomised in the study was much lower than planned. Although data from 5 subjects were used in the CHF6563 treatment group, only 2 subjects completed the s
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 |
Why NCT04104646 stopped before completion
NCT04104646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Morphine is the first listed.
NCT04104646 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04104646's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI