SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cachexia	Drug: Placebo comparator Drug: SUN11031	Phase II

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 to Subjects Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

Further study details as provided by Asubio Pharmaceuticals, Inc.:

Primary Outcome Measures:

The physical performance [ Time Frame: Between Baseline (Days -6 to -3) and the end of 12 weeks of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	225
Study Start Date:	March 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental SUN11031 for injection, low dose, twice daily for 12 weeks	Drug: SUN11031 Twice daily subcutaneous injections of SUN11031 for 12 weeks.
Group 2: Experimental SUN11031 for injection, higher dose, twice daily for 12 weeks	Drug: SUN11031 Twice daily subcutaneous injections of SUN11031 for 12 weeks.
Group 3: Placebo Comparator Placebo injection, twice daily for 12 weeks	Drug: Placebo comparator Twice daily subcutaneous injections of placebo for 12 weeks.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698828

Contacts


Contact: Carol A. Lewis-Cullinan, APRN, BC	401-369-7900 ext 112	carol.lewiscullinan@genexion.com

Locations


United States, Connecticut
	Waterbury Pulmonary Associates	Recruiting
	Waterbury, Connecticut, United States, 06708
	Contact: Katie Cleveland, LPN 203-759-3656 research@waterburypulmonary.com

United States, Florida
	Clinical Research of West Florida	Recruiting
	Clearwater, Florida, United States, 33765
	Contact: Sally Kastes, RN, CRC 727-466-0078 skastes@crwf.com

United States, Maryland
	The Center for Clinical Research, Washington County Hospital	Recruiting
	Hagerstown, Maryland, United States, 21740
	Contact: Kathelen Renee, CCRC 301-790-8598 krenee@wchsys.org

United States, Ohio
	New Horizons Clinical Research	Recruiting
	Cincinnati, Ohio, United States, 45252
	Contact: Cindy Young, RN 513-769-2767 cyoung@nhcr.com

United States, South Carolina
	Spartanburg Medical Research	Recruiting
	Spartanburg, South Carolina, United States, 29303
	Contact: Susan Miller, RTR, CCRC 864-583-1556 smiller@medresearch.com

Sponsors and Collaborators

Asubio Pharmaceuticals, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Asubio Pharmaceuticals, Inc. ( Ron Corey, PhD, MBA, Exec Dir, Clinical and Project Management )
Study ID Numbers:	ASBI 307
First Received:	May 1, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00698828
Health Authority:	United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:

Cachexia, COPD, Chronic Obstructive Pulmonary Disease

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Weight Loss

Body Weight Changes

Cachexia

Emaciation

Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Asubio Pharmaceuticals, Inc.
Information provided by:	Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00698828