Comparison · NCT04040322-ba441b9d
Iloprost Injection, for Intravenous Use vs Placebo: Percentage of Responders
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Iloprost Injection, for Intravenous Use vs Placebo: Percentage of Responders. Trial comparisons, record NCT04040322-ba441b9d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04040322-ba441b9d
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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 | 0.333 | 0.248 | 0.431 | wilson | |
| Risk in group 2 | 0.34 | 0.254 | 0.439 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00687 | -0.137 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.98 | 0.661 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 0.97 | 0.536 | 1.75 | log | |
| Number needed to treat, for one fewer participant with the outcome on Iloprost Injection, for Intravenous Use than on Placebo | 145 | 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 | Iloprost Injection, for Intravenous Use | Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. Study drug will be initiated at a starting dose 0.5 ng/kg/min up to 2.0 ng/kg/min.~Iloprost Injection, for intravenous use: Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. | 33 | 99 | OG001 |
| Group 2 | Placebo | Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. Study drug will be initiated at a starting dose 0.5 ng/kg/min up to 2.0 ng/kg/min.~Placebo IV infusion: Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. | 33 | 97 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Responders
- Description
The responders are defined as participants that have at least 50% reduction in weekly total duration of symptomatic RP attacks and at least 50% reduction in overall severity from baseline.~Duration of symptomatic RP attacks and severity of attacks are obtained from electronic diary.
- Time frame
- From baseline (Day 10 to Day 25 of screening period) to the end of the efficacy follow-up (Day 8 to Day 21).
- Population
Source ClinicalTrials.gov
Trial
- Title
- Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
- NCT number
- NCT04040322
- Phases
- PHASE3
- Conditions
- Raynaud's Phenomenon Secondary to Systemic Sclerosis
- Interventions
- Placebo IV infusion, Iloprost Injection, for intravenous use
- Lead sponsor
- Civi Biopharma, Inc.
- Results first posted
- 2025-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04040322?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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