CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Dose 1 GSK2586881 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01597635
NCT01597635Phase 2Completed

A Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586881 in Patients With Acute Lung Injury

GlaxoSmithKline·interventional·Posted May 14, 2012·Updated Sep 28, 2017

In Brief

A Phase 2 clinical trial evaluating Dose 1 GSK2586881, Dose 2 GSK2586881, and 3 other interventions for Lung Injury, Acute. Completed, enrolled 44 participants across 19 sites in 2 countries.

Detailed Summary

This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The study has two parts: Part A will be an open-label investigation in five subjects. Part B will be a double-blind, placebo controlled investigation and will involve approximately 60 subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2012
Enrollment StartSep 1, 2012
Primary CompletionOct 1, 2014
Study CompletionOct 6, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.1 years ago

Interventions

Dose 1 GSK2586881drug

Low dose GSK2586881 administered intravenously

Dose 2 GSK2586881drug

Medium dose GSK2586881 administered intravenously

Dose 3 GSK2586881drug

Medium-High dose GSK2586881 administered intravenously

Dose 4 GSK2586881drug

High dose GSK2586881 administered intravenously

Placebo (saline)drug

Administered intravenously to match intervention