At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 227 enrolled
Drug / intervention
Placebo comparator +2 moredrug
Likely dose
SUN11031 20 μg/kgfrom 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.
A Phase 2b, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SUN11031 for Injection Administered Subcutaneously Twice Daily for 12 Weeks to Subjects Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
In Brief
A Phase 2 clinical trial evaluating Placebo comparator, SUN11031 20 μg/kg, and 1 other intervention for Cachexia. Completed, enrolled 227 participants across 43 sites in 6 countries.
Detailed Summary
To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCachexia
CountriesArgentina, Chile, Guatemala, Honduras, Romania, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedJun 2008
Primary CompletionOct 2009
TodayJul 2026
First PostedJun 17, 2008
Enrollment StartMay 15, 2008
Primary CompletionOct 8, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.0 years ago
Interventions
Placebo comparatordrug
Twice daily subcutaneous injections of placebo for 12 weeks.
SUN11031 20 μg/kgdrug
Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.
SUN11031 40 μg/kgdrug
Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.