NCT00917150

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
771

participants targeted

Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

5.1 years

First QC Date

June 8, 2009

Results QC Date

March 11, 2021

Last Update Submit

April 5, 2021

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary diseaseCOPDemphysema

Outcome Measures

Primary Outcomes (1)

  • Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months

    Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period.

    Baseline, 24 months

Secondary Outcomes (2)

  • Change From Baseline at 24 Months in Total Symptom Diary Score

    Baseline, 24 months

  • Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Baseline, 24 months

Study Arms (4)

OPC-6535 12.5mg

EXPERIMENTAL
Drug: tetomilast (OPC-6535)

OPC-6535 25mg

EXPERIMENTAL
Drug: tetomilast (OPC-6535)

OPC-6535 50mg

EXPERIMENTAL
Drug: tetomilast (OPC-6535)

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

tetomilast (OPC-6535)DRUG

oral administration of 12.5mg OPC-6535, once daily for 24months

OPC-6535 12.5mg
placeboDRUG

oral administration of placebo, once daily for 24months

placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Central China Area, China

Location

Unknown Facility

East China Area, China

Location

Unknown Facility

North China Area, China

Location

Unknown Facility

Northeast China Area, China

Location

Unknown Facility

Northwest China Area, China

Location

Unknown Facility

South China Area, China

Location

Unknown Facility

Southwest China Area, China

Location

Unknown Facility

Kansai Region, Et Al., Japan

Location

Unknown Facility

Seoul, Et Al., South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Interventions

tetomilast

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., LTD.
CL_OPCJ_RDA_Team@otsuka.jp
+81-3-6361-7366

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 30, 2021

Results First Posted

April 30, 2021

Record last verified: 2021-04

Locations

CN(7)JP(1)KR(1)