Comparison · NCT04104646-9910dc63
CHF6563 vs Morphine: Adjunctive Therapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CHF6563 vs Morphine: Adjunctive Therapy. Trial comparisons, record NCT04104646-9910dc63. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04104646-9910dc63
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.2 | 0.0362 | 0.624 | wilson | |
| Risk in group 2 | 0 | 0 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0.2 | -0.478 | 0.624 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on CHF6563 than on Morphine | 5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CHF6563 | Sublingual dose of CHF6563 and the corresponding oral dose of morphine matched placebo | 1 | 5 | OG000 |
| Group 2 | Morphine | Oral dose of morphine and the corresponding sublingual dose of CHF6563 matched placebo | 0 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Adjunctive Therapy
- Description
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
- Time frame
- up to 10 weeks after first dose
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
- NCT number
- NCT04104646
- Phases
- PHASE2
- Conditions
- Neonatal Opioid Withdrawal Syndrome
- Interventions
- CHF6563, Morphine, CHF6563 matched placebo, Morphine matched placebo
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Results first posted
- 2023-08-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04104646?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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