SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00698828
First received: May 1, 2008
Last updated: April 4, 2011
Last verified: April 2011

May 1, 2008
April 4, 2011
March 2008
September 2009   (final data collection date for primary outcome measure)
The physical performance [ Time Frame: Between Baseline (Days -6 to -3) and the end of 12 weeks of dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00698828 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cachexia
  • Drug: Placebo comparator
    Twice daily subcutaneous injections of placebo for 12 weeks.
  • Drug: SUN11031
    Twice daily subcutaneous injections of SUN11031 for 12 weeks.
  • Experimental: Group 1
    SUN11031 for injection, low dose, twice daily for 12 weeks
    Intervention: Drug: SUN11031
  • Experimental: Group 2
    SUN11031 for injection, higher dose, twice daily for 12 weeks
    Intervention: Drug: SUN11031
  • Placebo Comparator: Group 3
    Placebo injection, twice daily for 12 weeks
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
October 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or non-pregnant female subjects ≥50 years of age with a clinical diagnosis of COPD
  • Loss >5% of subject's usual body weight

Exclusion Criteria:

  • Severe anemia (hemoglobin ≤8 g/dL)
  • COPD exacerbation
  • Currently undergoing treatment or evaluation for cancer
  • Type I or type II diabetes mellitus or a fasting serum glucose of ≥115 mg/dL
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Chile,   Guatemala,   Honduras,   Romania
 
NCT00698828
ASBI 307
No
Ron Corey, PhD, MBA, Exec Dir, Clinical and Project Management, Asubio Pharmaceuticals, Inc.
Asubio Pharmaceuticals, Inc.
Not Provided
Not Provided
Asubio Pharmaceuticals, Inc.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP