CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Public ClinicalTrials.gov record NCT04104646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT04104646
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Industry
- Enrollment
- 7 participants
Conditions and interventions
Conditions
Interventions
- CHF6563 Drug
- CHF6563 matched placebo Drug
- Morphine Drug
- Morphine matched placebo Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 7 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2020
- Primary completion
- Dec 12, 2021
- Completion
- Dec 12, 2021
- Last update posted
- Aug 2, 2023
2020 – 2021
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical site 015 | Las Vegas | Nevada | 89102 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19144 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04104646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2023 · Synced May 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04104646 live on ClinicalTrials.gov.