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

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ClinicalTrials.gov Identifier: NCT00698828
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Cachexia Drug: Placebo comparator Drug: SUN11031 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. The physical performance [ Time Frame: Between Baseline (Days -6 to -3) and the end of 12 weeks of dosing ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698828


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Sponsors and Collaborators
Daiichi Sankyo, Inc.

Additional Information:
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00698828     History of Changes
Other Study ID Numbers: ASBI 307
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: October 2015

Keywords provided by Daiichi Sankyo, Inc.:
Cachexia, COPD, Chronic Obstructive Pulmonary Disease

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