Trial · NCT02113735
Safety and Efficacy Study of Acthar in Subjects With ARDS
NCT02113735, Phase 2, Withdrawn, Mallinckrodt
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Acthar in Subjects With ARDS. Trials, record NCT02113735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02113735
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Acthar in Subjects With ARDS
- NCT number
- NCT02113735
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- H.P. Acthar® Gel (repository corticotropin injection), Placebo
- First posted
- 2014-04-15
- Last updated
- 2017-09-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of ventilator-free days (subjects alive and breathing without assistance for ≥ 48 hr) by Day 28 after randomization | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Mortality at Day 28 and Day 60 | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Number of ICU-free and hospital free days for all subjects who survive to ICU and hospital discharge, respectively | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Number of extra-pulmonary organ failure-free days | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Change in PaO2/FiO2 ratio and oxygenation index (OI) from baseline for subjects on mechanical ventilation | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Change in Systemic Organ Failure Assessment Score (SOFA) score from baseline. | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Number of treatment-emergent serious adverse events | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Number, severity and site of new infections developing at least 48 hr after initiation of Study Medication | 60 days (28 days of treatment with a 32 day follow-up period) | |
| Secondary | Proportion of subjects who discontinue treatment because of serious safety concerns | 60 days (28 days of treatment with a 32 day follow-up period) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02113735
GET https://conductscience.org/api/trials/v1/NCT02113735/registered