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To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00917150
First received: June 8, 2009
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: tetomilast (OPC-6535)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Trough FEV1 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptom diary score , QOL, CT etc. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 771
Study Start Date: March 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-6535 12.5mg Drug: tetomilast (OPC-6535)
oral administration of 12.5mg OPC-6535, once daily for 24months
Experimental: OPC-6535 25mg Drug: tetomilast (OPC-6535)
oral administration of 25mg OPC-6535, once daily for 24months
Experimental: OPC-6535 50mg Drug: tetomilast (OPC-6535)
oral administration of 50 mg OPC-6535, once daily for 24months
Placebo Comparator: placebo Drug: placebo
oral administration of placebo, once daily for 24months

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40 to 75 years, inclusive, at the time informed consent is obtained
  • Ability to provide own written informed consent
  • Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
  • A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
  • Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
  • Cigarette smoking history of at least 20 pack years at screening

Exclusion Criteria:

  • Subjects with obstructive disorders due to bronchial asthma
  • Subjects receiving long-term oxygen therapy
  • Subjects with active tuberculosis or obvious bronchiectasis
  • Complication of malignant tumor
  • Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
  • Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917150

Locations
China
Central China Area, China
East China Area, China
North China Area, China
Northeast China Area, China
Northwest China Area, China
South China Area, China
Southwest China Area, China
Japan
Kansai Region, et al., Japan
Korea, Republic of
Seoul, et al., Korea, Republic of
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00917150     History of Changes
Other Study ID Numbers: 197-08-801, JapicCTI-090770
Study First Received: June 8, 2009
Last Updated: June 9, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
chronic obstructive pulmonary disease
COPD
emphysema

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 19, 2014