Clinical Trial: SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief Summary: To evaluate SUN11031 for 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.
Detailed Summary:
Sponsor: Daiichi Sankyo Inc.
Current Primary Outcome: The physical performance [ Time Frame: Between Baseline (Days -6 to -3) and the end of 12 weeks of dosing ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability data as measured by adverse events, electrocardiograms, physical exams, clinical laboratory tests, vital signs, and lung function [ Time Frame: From Baseline (Days -6 to -3) to the end of 12 weeks of dosing and 2 weeks post-treatment ]
- Evaluate the effect of SUN11031 on body composition data [ Time Frame: From Baseline (Days -6 to -3) to the end of 12 weeks of dosing and 2 weeks post-treatment follow-up ]
Original Secondary Outcome: Same as current
Information By: Daiichi Sankyo Inc.
Dates:
Date Received: May 1, 2008
Date Started: March 2008
Date Completion:
Last Updated: October 19, 2015
Last Verified: October 2015
