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Safety and Efficacy Study of Acthar in Subjects With ARDS

NCT02113735 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-09-27

No results posted yet for this study

Summary

This study is being performed to evaluate the potential efficacy and safety of Acthar as a treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a blinded gradually tapering regimen, and subjects will be followed for 60 days post-randomization.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

H.P. Acthar® Gel (repository corticotropin injection)

DRUG

Placebo

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02113735 on ClinicalTrials.gov