Comparison · NCT04030026-0308fd7f
NAL ER vs Placebo: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
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. NAL ER vs Placebo: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG). Trial comparisons, record NCT04030026-0308fd7f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04030026-0308fd7f
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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 | 0.0263 | 0.00466 | 0.135 | wilson | |
| Risk in group 2 | 0.025 | 0.00443 | 0.129 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00132 | -0.105 | 0.112 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.0682 | 16.2 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.0636 | 17.5 | log | |
| Number needed to treat, for one more participant with the outcome on NAL ER than on Placebo | 760 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | NAL ER | Participants received NAL ER 27 mg QD to 54 mg BID over a 5-day period, and then maintained at 54 mg BID for 4 days. Dose was increased to 108 mg BID for 1 week followed by 162 mg, BID for 6 days in treatment period 1 or 2 of the study. | 1 | 38 | OG000 |
| Group 2 | Placebo | Participants received placebo for 3 weeks through treatment period 1 or 2 of the study. | 1 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
- Description
Changes in ECG data such as heart rate, rhythm, and other clinically significant abnormalities (left ventricular hypertrophy, pathological Q-waves) were measured. Clinical significance was determined by the investigator.
- Time frame
- Up to Day 72
- Population
SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
Source ClinicalTrials.gov
Trial
- Title
- A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
- NCT number
- NCT04030026
- Phases
- PHASE2
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- NAL ER, Placebo
- Lead sponsor
- Trevi Therapeutics
- Results first posted
- 2025-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04030026?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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