ID

37323

Description

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains urinalysis and urine microscopy data, which are assessed at Screening, on Day 2 at 0 hrs, Day 3 at 0 hrs, Day 3 at 24 hrs (i.e. Day 4 at 0 hrs), and Follow-Up (for all cohorts). This form can also be used for any repeat/unscheduled urine laboratory tests.

Link

https://clinicaltrials.gov/ct2/show/NCT00996840

Keywords

Versions (2)

1. 7/16/19 7/16/19 -
2. 7/17/19 7/17/19 - Sarah Riepenhausen

Copyright Holder

GlaxoSmithKline

Uploaded on

July 17, 2019

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