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Trials / Completed

CompletedNCT01502631

Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
65 (actual)
Sponsor
Daiichi Sankyo · Industry
Sex
All
Age
16 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord injury.

Conditions

Interventions

TypeNameDescription
DRUGSUN13837 injectionSUN13837 injection, injection 1 x daily for 28 doses
DRUGPlaceboMatching placebo, volume equivalent to injection 1 x daily for 28 doses

Timeline

Start date
2012-08-08
Primary completion
2014-09-21
Completion
2014-09-21
First posted
2012-01-02
Last updated
2021-01-15
Results posted
2021-01-15

Locations

67 sites across 7 countries: United States, Canada, Czechia, France, Poland, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT01502631. Inclusion in this directory is not an endorsement.

Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal C (NCT01502631) · Clinical Trials Directory