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

NCT ID: NCT00698828

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-15
• Study Completion Date: 2009-10-08

Brief Summary

To evaluate SUN11031 for subcutaneous 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.

Conditions

Cachexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

SUN11031 for injection, low dose, twice daily for 12 weeks

Group Type: EXPERIMENTAL

SUN11031 20 μg/kg

Intervention Type: DRUG

Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.

Group 2

SUN11031 for injection, higher dose, twice daily for 12 weeks

Group Type: EXPERIMENTAL

SUN11031 40 μg/kg

Intervention Type: DRUG

Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.

Group 3

Placebo injection, twice daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

Twice daily subcutaneous injections of placebo for 12 weeks.

Interventions

Placebo comparator

Twice daily subcutaneous injections of placebo for 12 weeks.

Intervention Type: DRUG

SUN11031 20 μg/kg

Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.

Intervention Type: DRUG

SUN11031 40 μg/kg

Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Each participant had to meet the following criteria to be enrolled in the study:

1. Male or non-pregnant female participants 50 years or older with a clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for greater than or equal to 12 months

2. Walked a distance of greater than or equal to 100 but less than or equal to 450 meters during the 6-Minute Walk Test (MWT) performed at screening.

3. Chest x-ray within the past year that was compatible with COPD

4. Documented involuntary nonedematous weight loss of greater than 5% of participant's usual body weight over the past 12 months or BMI less than or equal to 21 kg/m^2 for males or Body Mass Index (BMI) less than or equal to 20 kg/m^2 for females

5. Female participants who were clinically sterile (eg, either postmenopausal or had undergone a tubal ligation or hysterectomy) or were practicing a medically acceptable method of birth control (eg, oral, transdermal, implantable, or injectable contraceptive medications; double-barrier method or intrauterine device)

Exclusion Criteria

Participants who met any of the following criteria were excluded from the study:

1. BMI greater than 26 kg/m^2

2. Used, over a total of 7 or more days, parenteral corticosteroids at a dose equivalent to prednisone at greater than or equal to 5 mg/day or oral corticosteroids at a dose equivalent to prednisone at greater than 10 mg/day within the 2 months before screening; however, participants were allowed to participate if on stable doses equivalent to prednisone at less than or equal to 10 mg/day for at least 2 months before screening, and were planning to remain on the same stable dose throughout the study

3. Were planning to start a pulmonary rehabilitation program during the study (participant may have been enrolled in the study if he or she was currently on a stable maintenance program)

4. Weight loss that was considered to be, in the opinion of the investigator, the result of food deprivation

5. Unintended weight loss that may have been due to disease other than COPD

6. Unable or unwilling to be trained to self-administer the study drug by subcutaneous injection bid, and for whom arrangements could not be made for a third party to reliably administer the injections

7. Severe anemia (hemoglobin less than or equal to 8 g/dL)

8. COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg criteria, acute infection, or prolonged fever within 4 weeks before screening

9. Undergoing treatment or evaluation for cancer, or had a history of treatment for cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or squamous cell carcinoma of the skin) and carcinoma in situ of the cervix

10. Type I or type II diabetes mellitus or a fasting serum glucose of greater than or equal to 115 mg/dL (6.4 mmol/L) (fasting was overnight)

11. Serious disease or conditions that would have interfered with the participant's ability to complete the functional measures included in this protocol; or any illness that, in the opinion of the investigator, might have interfered with the results of the study or the participant's ability to participate

12. Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months

13. Significant ischemic heart disease or chronic heart failure (New York Heart Association Class IV cardiac disease)

14. Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 110 mm Hg)

15. A history of symptomatic orthostatic hypotension or syncope; or orthostatic hypotension at screening or baseline (Days -6 to -3) (orthostatic hypotension was defined as a decrease in systolic blood pressure by greater than or equal to 20 mm Hg measured after 2 minutes in a standing position compared with the systolic blood pressure measured after 10 minutes in a supine position)

16. Evidence of ascites, pleural effusion, or lower extremity edema

17. Severe vitamin D deficiency (25-hydroxyvitamin D less than 10 ng/mL)

18. Known mechanical obstruction of the alimentary tract and/or malabsorption

19. Dental or swallowing problems that may have had a negative effect on food intake

20. Serum creatinine greater than 2.5 mg/dL; or alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase greater than 3 times the upper limit of normal, or bilirubin greater than 2.5 mg/dL

21. A diagnosis of human immunodeficiency virus infection or AIDS

22. Used any prescription drugs and non-prescription drugs/herbs that cause weight loss or affect appetite and absorption or that may cause nausea; or used appetite-promoting or anabolic medications within 15 days before screening

23. A history of alcohol or drug abuse that, in the opinion of the investigator, would have interfered with the participant's ability to comply with the dosing schedule and protocol-specified requirements

24. Hypersensitive to any component of SUN11031, or participated at any time in any study in which SUN11031 was administered

25. Received an investigational drug or product, or participated in a drug study within 30 days before screening

26. Non-ambulatory or unwilling to cooperate fully with the investigator or a designee, or unwilling or unable to comply with study requirements, such as all assessments required by the protocol, including completion of measures for functional capacity and pulmonary function, or frequent blood sampling and meal instructions; or unable or unwilling to attend all study visits

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Waterbury Pulmonary Associates

Waterbury, Connecticut, United States

Clinical Research of West Florida

Clearwater, Florida, United States

Innovative Research of West Florida

Largo, Florida, United States

The Center for Clinical Research, Washington County Hospital

Hagerstown, Maryland, United States

Montana Medical Research, Inc.

Missoula, Montana, United States

The Asthma & Allergy Center

Papillion, Nebraska, United States

Health Science Research Center - Asthma & Allergy Associates

Cortland, New York, United States

New Horizons Clinical Research

Cincinnati, Ohio, United States

Clinical Research Institute of Southern Oregon

Medford, Oregon, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Pulmonary Consultants

Tacoma, Washington, United States

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

Instituto de Investigaciones Clínicas Cipolletti

Cipolletti, Río Negro Province, Argentina

Clinica del Tórax

Rosario, Santa Fe Province, Argentina

Instituto Cardiovascular de Rosario

Rosario, Santa Fe Province, Argentina

CEMIT

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigación Médica Lanús

Buenos Aires, , Argentina

FAICEP

Capital Federal, , Argentina

Instituto Médico de Asistencia e Investigación

Capital Federal, , Argentina

Centro Médico Dra. De Salvo

Capital Federal, , Argentina

Centro Médico Belgrano

Capital Federal, , Argentina

Centro Ceri

Capital Federal, , Argentina

Centro de Estudios Neumonologicos

Capital Federal, , Argentina

Fuesmen

Mendoza, , Argentina

Instituto de Enfermedades Respiratorias

Mendoza, , Argentina

Centro de Medicina Respiratoria

Paraná, , Argentina

Instituto de Patologia Respiratoria

San Miguel de Tucumán, , Argentina

Hospital Barros Luco Trudeau

Santiago, , Chile

Hospital San Jose

Santiago, , Chile

Integramedica La Florida

Santiago, , Chile

Instituto Pneos

Guatemala City, , Guatemala

Edificio Centro Medico II

Guatemala City, , Guatemala

Private Clinic

Guatemala City, , Guatemala

Edificio Medico San Lucas

Quetzaltenango, , Guatemala

Centro de Neumologia y Alergia

San Pedro Sula, , Honduras

Instituto Nacional Cardiopulmonar

Tegucigalpa, , Honduras

Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Spitalul Clinic de Boli Infectioase si Pneumoftiziologoe "Dr. Victor Babes"

Timișoara, Timiș County, Romania

Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca

Cluj-Napoca, , Romania

Spitalul Clinic de Pneumoftiziologie Constanta, Cartier Palazul Mare

Constanța, , Romania

Spitalul Clinic Judetean Sibiu, Clinica Medicala

Sibiu, , Romania

Countries

United States; Argentina; Chile; Guatemala; Honduras; Romania

Related Links

http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html

Related Info

Other Identifiers

ASBI 307

Identifier Type: -

Identifier Source: org_study_id