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Trial record 1 of 1 for:    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
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CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome (NOWSHINE)

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ClinicalTrials.gov Identifier: NCT04104646
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE September 24, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE January 26, 2021
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
Duration of treatment defined as the number of hours from first dose of study drug administration until the last dose of study drug [ Time Frame: up to 10 weeks after first dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • Time to first weaning, defined as the number of hours from first dose of study drug administration until the first dose reduction [ Time Frame: up to 10 weeks after first dose ]
  • Requirement for adjunctive drug therapy (phenobarbital) for signs of NOWS [ Time Frame: up to 10 weeks after first dose ]
  • Total hours of treatment with adjunctive therapy [ Time Frame: up to 10 weeks after first dose ]
  • Requirement for rescue doses (CHF6563 or morphine) [ Time Frame: up to 10 weeks after first dose ]
  • Percentage of total dose which is from rescue doses [ Time Frame: up to 10 weeks after first dose ]
  • Length of opioid related hospital stay, defined as number of days from day of birth until 48 hours after the final dose of drug treatment for NOWS [ Time Frame: up to 10 weeks plus 48 hours ]
  • Relapse of NOWS, defined as experiencing recurrence of significant signs of withdrawal [ Time Frame: up to 6 weeks after last dose ]
  • Incidence of readmissions, defined as readmission to hospital for NOWS relapse [ Time Frame: up to 6 weeks after last dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
double blind, double-dummy
Primary Purpose: Treatment
Condition  ICMJE Neonatal Opioid Withdrawal Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: CHF6563
    Sublingual dose of CHF6563 and the corresponding oral dose of morphine matched placebo
    Interventions:
    • Drug: CHF6563
    • Drug: Morphine matched placebo
  • Active Comparator: Morphine
    Oral dose of morphine and the corresponding sublingual dose of CHF6563 matched placebo.
    Interventions:
    • Drug: Morphine
    • Drug: CHF6563 matched placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
99
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent obtained by parents/legal representative(according to local regulation) prior to or after birth.
  2. Birth weight ≥ 3rd centile for gestational age (GA), according to the CDC growth chart
  3. Gestational age ≥ 36 weeks
  4. Exposure to opioids during the last month of fetal life
  5. Signs of neonatal opioid withdrawal syndrome requiring treatment, and the sum of 3 consecutive FNAST scores is ≥ 24 or a single score ≥ 12

Exclusion Criteria:

  1. Familial history of prolonged QTc syndrome
  2. Major congenital malformations or evidence of congenital infection
  3. Signs of fetal alcohol spectrum disorders
  4. Maternal alcohol abuse, defined as average of 3 or more drinks per week in the last 30 days
  5. Medical illness at the time of randomization, including but not exclusively:

    1. Neonatal hypoglycemia requiring intravenous glucose therapy
    2. Neonatal respiratory illness requiring non-invasive or invasive respiratory support
    3. Neonatal encephalopathy (including hypoxic ischemic encephalopathy or seizures
    4. Severe hyperbilirubinemia-bilirubin at or above the exchange transfusion threshold as defined by the AAP
    5. Severe elevation of serum aminotransferases (more than twice the upper limit of the age appropriate aminotransferases reference range of the investigational site).
    6. Proven or suspected early onset neonatal infection which will require more than 48hours treatment with antibiotics
  6. Unable to tolerate an oral or sublingual medication
  7. Need for medications forbidden in this study protocol
  8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
  9. Participation in another clinical trial of any medicinal product, placebo, experimental medical device or biological substance conducted under the provisions of a protocol on the same therapeutic target. The participation in studies involving diagnostic devices or treatments for conditions other than NOWS and NAS may be permitted following an agreement with the Sponsor. Non-interventional observational studies are allowed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trial Info +39.0521 2791 clinicaltrials_info@chiesi.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04104646
Other Study ID Numbers  ICMJE CLI-06563AA1-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Walter Kraft Thomas Jefferson University
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP