# CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

> **NCT04104646** · PHASE2 · TERMINATED · sponsor: **Chiesi Farmaceutici S.p.A.** · enrollment: 7 (actual)

## Conditions studied

- Neonatal Opioid Withdrawal Syndrome

## Interventions

- **DRUG:** CHF6563
- **DRUG:** Morphine
- **DRUG:** CHF6563 matched placebo
- **DRUG:** Morphine matched placebo

## Key facts

- **NCT ID:** NCT04104646
- **Lead sponsor:** Chiesi Farmaceutici S.p.A.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-12-18
- **Primary completion:** 2021-12-13
- **Final completion:** 2021-12-13
- **Target enrollment:** 7 (ACTUAL)
- **Why stopped:** Low recruitment rate
- **Last updated:** 2023-08-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04104646

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04104646, "CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04104646. Licensed CC0.

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