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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

Tracking Information
First Submitted Date  ICMJE May 1, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date November 6, 2015
Study Start Date  ICMJE March 2008
Actual 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 ]
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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: June 13, 2008)
225
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Guatemala,   Honduras,   Romania,   United States
Removed Location Countries Bulgaria
 
Administrative Information
NCT Number  ICMJE NCT00698828
Other Study ID Numbers  ICMJE ASBI 307
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date October 2015

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