Trial · NCT04104646
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
NCT04104646, Phase 2, Terminated, Chiesi Farmaceutici S.p.A.; results first posted 2023-08-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome. Trials, record NCT04104646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04104646
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
- NCT number
- NCT04104646
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Neonatal Opioid Withdrawal Syndrome
- Interventions
- CHF6563, Morphine, CHF6563 matched placebo, Morphine matched placebo
- First posted
- 2019-09-26
- Last updated
- 2023-08-03
- Results first posted
- 2023-08-03
- Limitations and caveats
The study objectives could not be addressed because the study was terminated due to a low recruitment; for non-safety reasons.~Despite concerted efforts by the Sponsor to improve the enrolment rate (e.g., through communications with the Investigators, changing the training modalities to meet nurses' requests, and decreasing the sample size), the projected time frame to complete the study was longer than 5 years; this was considered unacceptable for the clinical development programme.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Treatment | Up to 10 weeks after first dose | 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 study as planned i.e. 1 subject in each study arm; no imputation of missing or incomplete data was possible according to the methods defined in the study protocol and the SAP. No statistical analysis was performed. |
| Secondary | Time to First Weaning | up to 10 weeks after first dose | Record the time to first weaning, defined as the number of hours from first dose of study drug administration until the first dose reduction. 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 study as planned i.e. 1 subject in each study arm; no imputation of missing or incomplete data was possible according to the methods defined in the study protocol and the SAP. No statistical analysis was performed. |
| Secondary | Adjunctive Therapy | up to 10 weeks after first dose | Record the requirement for adjunctive drug therapy (phenobarbital) for signs of NOWS, recorded as Yes/No. Overall, 1 subject in the CHF6563 group and zero subjects in the morphine were reported as having received adjunctive drug therapy with phenobarbital. The number of subjects randomised in the study was much lower than planned. No imputation of missing or incomplete data was made. No statistical analysis was performed. NOWS=Neonatal Opioid Withdrawal Syndrome |
| Secondary | Requirement for Rescue Doses (CHF6563 or Morphine) | up to 10 weeks after first dose | Requirement for rescue doses and number of rescue doses administered (CHF6563 or morphine); (yes/no). The number of subjects randomised in the study was lower than planned. No imputation of missing or incomplete data was made. No statistical analysis was performed. |
| Secondary | Number of Rescue Doses Administered | up to 10 weeks after first dose | Number of rescue doses administered. 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 study as planned i.e. 1 subject in each study arm; no imputation of missing or incomplete data was possible according to the methods defined in the study protocol and the SAP. No statistical analysis was performed. At the discretion of the physician, a rescue dose of CHF6563 or morphine could be given during the up-titration phase or during the weaning phases to a neonate who had a single FNAST score ≥12. A rescue dose was not to be administered within 1 hour of the previous dose or 1 hour before the next scheduled dose. Rescue doses were the same as the previous dose. |
| Secondary | Length of Opioid-related Hospital Stay | up to 10 weeks plus 48 hours | Length of opioid-related hospital stay was defined as number of days from day of birth until 48 hours after the final dose of drug treatment for NOWS. Reported data show the 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). 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 study as planned i.e. 1 subject in each study arm; no imputation of missing or incomplete data was possible according to the methods defined in the study protocol and the SAP. No statistical analysis was performed. |
| Secondary | Relapse of NOWS | up to 6 weeks after last dose | Relapse of NOWS, defined as experiencing recurrence of significant signs of withdrawal . Reported are subjects with experiencing a relapse. The number of subjects randomised in the study was much lower than planned. No imputation of missing or incomplete data was made. No statistical analysis was performed. NOWS=Neonatal Opioid Withdrawal Syndrome |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Treatment | Up to 10 weeks after first dose | Randomised Set: All randomised subjects. Only 7 subjects were randomised into the study; 2 subjects completed the study as planned; therefore, no statistical analysis was performed.~Due to low recruitment rate, the study was terminated early for non-safety reasons. | hours | MEAN |
| SECONDARY | Time to First Weaning | up to 10 weeks after first dose | Randomised Set: All randomised subjects. Only 7 subjects were randomised into the study; 2 subjects completed the study as planned; therefore, no statistical analysis was performed.~Due to low recruitment rate, the study was terminated early for non-safety reasons. | hours | MEAN |
| SECONDARY | Adjunctive Therapy | up to 10 weeks after first dose | Randomised Set: All randomised subjects. Only 7 subjects were randomised into the study; 2 subjects completed the study as planned; therefore, no statistical analysis was performed.~Due to low recruitment rate, the study was terminated early for non-safety reasons. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Requirement for Rescue Doses (CHF6563 or Morphine) | up to 10 weeks after first dose | Randomised Set: All randomised subjects. Only 7 subjects were randomised into the study; 2 subjects completed the study as planned; therefore, no statistical analysis was performed.~Due to low recruitment rate, the study was terminated early for non-safety reasons. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Rescue Doses Administered | up to 10 weeks after first dose | Randomised Set: All randomised subjects. Only 7 subjects were randomised into the study; 2 subjects completed the study as planned; therefore, no statistical analysis was performed.~Due to low recruitment rate, the study was terminated early for non-safety reasons. | number of rescue doses | MEAN |
| SECONDARY | Length of Opioid-related Hospital Stay | up to 10 weeks plus 48 hours | Randomised Set: All randomised subjects. Only 7 subjects were randomised into the study; 2 subjects completed the study as planned; therefore, no statistical analysis was performed.~Due to low recruitment rate, the study was terminated early for non-safety reasons. | days | MEAN |
| SECONDARY | Relapse of NOWS | up to 6 weeks after last dose | Randomised Set: All randomised subjects. Only 7 subjects were randomised into the study; 2 subjects completed the study as planned; therefore, no statistical analysis was performed.~Due to low recruitment rate, the study was terminated early for non-safety reasons. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Treatment | CHF6563 | All treated patients | 157.62 | Full Range 3.8 to 547.7 | hours |
| Duration of Treatment | Morphine | All treated patients | 570.85 | Full Range 501.5 to 640.2 | hours |
| Duration of Treatment | CHF6563 | Patients who completed the study (With Non Missing Data) | 547.7 | Full Range 547.7 to 547.7 | hours |
| Duration of Treatment | Morphine | Patients who completed the study (With Non Missing Data) | 501.5 | Full Range 501.5 to 501.5 | hours |
| Time to First Weaning | CHF6563 | All Treated Patients | 120.3 | Full Range 120.3 to 120.3 | hours |
| Time to First Weaning | Morphine | All Treated Patients | 56.2 | Full Range 40.4 to 72.0 | hours |
| Time to First Weaning | CHF6563 | Patients who completed the study (With Non Missing Data) | 120.3 | Full Range 120.3 to 120.3 | hours |
| Time to First Weaning | Morphine | Patients who completed the study (With Non Missing Data) | 72 | Full Range 72 to 72 | hours |
| Adjunctive Therapy | CHF6563 | 1 | Participants | ||
| Adjunctive Therapy | Morphine | 0 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CHF6563 | 5 | |
| Overall Study | STARTED | Morphine | 2 | |
| Overall Study | COMPLETED | CHF6563 | 1 | |
| Overall Study | COMPLETED | Morphine | 1 | |
| Overall Study | NOT COMPLETED | CHF6563 | 4 | |
| Overall Study | NOT COMPLETED | Morphine | 1 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | CHF6563 | 1 | 5 | 1 |
| other | Vomiting | Gastrointestinal disorders | Morphine | 0 | 2 | 0 |
| other | Flatulence | Gastrointestinal disorders | CHF6563 | 0 | 5 | 0 |
| other | Flatulence | Gastrointestinal disorders | Morphine | 1 | 2 | 1 |
| other | Fungal infection | Infections and infestations | CHF6563 | 0 | 5 | 0 |
| other | Fungal infection | Infections and infestations | Morphine | 1 | 2 | 1 |
| other | Skin candida | Infections and infestations | CHF6563 | 0 | 5 | 0 |
| other | Skin candida | Infections and infestations | Morphine | 1 | 2 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | CHF6563 | 0 | 5 | 0 |
| other | Rash | Skin and subcutaneous tissue disorders | Morphine | 1 | 2 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CHF6563 | 0 | 5 |
| Total, all-cause mortality | Morphine | 0 | 2 |
| Total, other adverse events | CHF6563 | 2 | 5 |
| Total, other adverse events | Morphine | 2 | 2 |
| Total, serious adverse events | CHF6563 | 0 | 5 |
| Total, serious adverse events | Morphine | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CHF6563 vs Morphine: Relapse of NOWS | Trial comparisons |
| CHF6563 vs Morphine: Adjunctive Therapy | Trial comparisons |
| CHF6563 vs Morphine: deaths from any cause | Trial comparisons |
| CHF6563 vs Morphine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04104646
GET https://conductscience.org/api/trials/v1/NCT04104646/results?page=2