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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 1, 2008
Last Updated Date	April 4, 2011
Start Date ^ICMJE	March 2008
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 13, 2008)	The physical performance [ Time Frame: Between Baseline (Days -6 to -3) and the end of 12 weeks of dosing ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00698828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 13, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)
Official Title ^ICMJE	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
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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Cachexia
Intervention ^ICMJE	Drug: Placebo comparator Twice daily subcutaneous injections of placebo for 12 weeks. Drug: SUN11031 Twice daily subcutaneous injections of SUN11031 for 12 weeks.
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	225
Completion Date	October 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Chile, Guatemala, Honduras, Romania

Administrative Information
NCT Number ^ICMJE	NCT00698828
Other Study ID Numbers ^ICMJE	ASBI 307
Has Data Monitoring Committee	No
Responsible Party	Ron Corey, PhD, MBA, Exec Dir, Clinical and Project Management, Asubio Pharmaceuticals, Inc.
Study Sponsor ^ICMJE	Asubio Pharmaceuticals, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asubio Pharmaceuticals, Inc.
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top