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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.

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

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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


  Hide Study Locations
Locations
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United States, Connecticut
Waterbury Pulmonary Associates
Waterbury, Connecticut, United States, 06708
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Innovative Research of West Florida
Largo, Florida, United States, 33756
United States, Maryland
The Center for Clinical Research, Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Montana
Montana Medical Research, Inc.
Missoula, Montana, United States, 59808
United States, Nebraska
The Asthma & Allergy Center
Papillion, Nebraska, United States, 68046
United States, New York
Health Science Research Center - Asthma & Allergy Associates
Cortland, New York, United States, 13045
United States, Ohio
New Horizons Clinical Research
Cincinnati, Ohio, United States, 45252
United States, Oregon
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States, 97504
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Washington
Pulmonary Consultants
Tacoma, Washington, United States, 98405
Argentina
Centro de Investigaciones Médicas
Florencío Varela, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, Argentina, B1878FNR
Instituto de Investigaciones Clínicas Cipolletti
Cipolletti, Río Negro, Argentina, R8324EMD
Clinica del Tórax
Rosario, Santa Fe, Argentina, S2000DBS
Instituto Cardiovascular de Rosario
Rosario, Santa Fe, Argentina, S2000DSV
CEMIT
San Miguel de Tucumán, Tucumán, Argentina
Centro de Investigación Médica Lanús
Buenos Aires, Argentina
FAICEP
Capital Federal, Argentina, C1122AAK
Instituto Médico de Asistencia e Investigación
Capital Federal, Argentina, C1425AWC
Centro Médico Dra. De Salvo
Capital Federal, Argentina, C1426ABP
Centro Médico Belgrano
Capital Federal, Argentina, C1429BNQ
Centro Ceri
Capital Federal, Argentina
Centro de Estudios Neumonologicos
Capital Federal, Argentina
Centro de Medicina Respiratoria
Entre Rios, Argentina
Fuesmen
Mendoza, Argentina, cp 5500
Instituto de Enfermedades Respiratorias
Mendoza, Argentina
Instituto de Patologia Respiratoria
Tucuman, Argentina
Chile
Hospital Barros Luco Trudeau
Santiago, Chile
Hospital San Jose
Santiago, Chile
Integramedica La Florida
Santiago, Chile
Guatemala
Instituto Pneos
Guatemala, Guatemala, 01010
Edificio Centro Medico II
Guatemala, Guatemala
Private Clinic
Guatemala, Guatemala
Edificio Medico San Lucas
Quetzaltenango, Guatemala
Honduras
Centro de Neumologia y Alergia
San Pedro Sula, Honduras
Instituto Nacional Cardiopulmonar
Tegucigalpa, Honduras
Romania
Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca
Cluj-Napoca, Cluj, Romania, 400371
Spitalul Clinic de Boli Infectioase si Pneumoftiziologoe "Dr. Victor Babes"
Timişoara, Timiş, Romania, 300310
Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca
Cluj-Napoca, Romania, 400371
Spitalul Clinic de Pneumoftiziologie Constanta, Cartier Palazul Mare
Constanţa, Romania, 900002
Spitalul Clinic Judetean Sibiu, Clinica Medicala
Sibiu, Romania, 550245
Sponsors and Collaborators
Daiichi Sankyo, Inc.

Additional Information:
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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:
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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