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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
SUN11031 for injection, low dose, twice daily for 12 weeks
 Drug: SUN11031
Twice daily subcutaneous injections of SUN11031 for 12 weeks.
Experimental: Group 2
SUN11031 for injection, higher dose, twice daily for 12 weeks
 Drug: SUN11031
Twice daily subcutaneous injections of SUN11031 for 12 weeks.
Placebo Comparator: Group 3
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

  Show 43 Study Locations
Sponsors and Collaborators
Asubio Pharmaceuticals, Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ron Corey, PhD, MBA, Exec Dir, Clinical and Project Management, Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00698828     History of Changes
Other Study ID Numbers: ASBI 307
Study First Received: May 1, 2008
Last Updated: April 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:
Cachexia, COPD, Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Cachexia
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Emaciation
 Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013