UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000233 |
|---|---|
| Receipt number | R000000269 |
| Scientific Title | A randomized, placebo controlled, parallel-group, multicenter clinical trial to evaluate the preventive effect on acute exacerbation of chronic obstructive pulmonary disease (COPD) with Carbocisteine (1500mg/day) |
| Date of disclosure of the study information | 2006/12/01 |
| Last modified on | 2007/03/20 17:14:36 |
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Basic information
Public title
A randomized, placebo controlled, parallel-group, multicenter clinical trial to evaluate the preventive effect on acute exacerbation of chronic obstructive pulmonary disease (COPD) with Carbocisteine (1500mg/day)
Acronym
Preventive effect on acute exacerbation of chronic obstructive pulmonary disease with Carbocisteine (PEACE Study)
Scientific Title
A randomized, placebo controlled, parallel-group, multicenter clinical trial to evaluate the preventive effect on acute exacerbation of chronic obstructive pulmonary disease (COPD) with Carbocisteine (1500mg/day)
Scientific Title:Acronym
Preventive effect on acute exacerbation of chronic obstructive pulmonary disease with Carbocisteine (PEACE Study)
Region
| Asia(except Japan) |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive effect of acute exacerbation in COPD patient (StageII-IV) with Carbocisteine (1500mg/day) for 13 months treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of exacerbations
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carbocisteine group
1500mg/day (13 months)
Interventions/Control_2
Placebo group (13 months)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Stable COPD patient (Stage II-IV)
2. Between 40 and 80 years
3. Out-patient
4. Written informed consent
5. At least 2 exacerbations in the previous 2 years
Key exclusion criteria
1. Intolerance for Carbocisteine
2. Use of mucolytic agents within one month prior to beginning of the study
3. Use of antibiotics at the beginning of the study
4. Bronchiectasis, pneumonia, interstitial lung disease, tuberculosis
5. Carcinoma
6. Previous lung transplant or lung volume reduction surgery
7. Pregnant or breastfeeding
8. Attendance in the other study within 3 months prior to the beginning of the study
9. Underlying severe disease
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nan-Shan Zhong |
Organization
Guangzhou Institute of Respiratory Diseases
Division name
Director
Zip code
Address
151 Yanjiang Rd, Guangzhou, China
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyorin Pharmaceutical Co., LTD
Division name
P. L. C. Management Dept.
Zip code
Address
5, Kanda Surugadai, 2-Chome Chiyoda-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Kyorin Pharmaceutical Co., LTD
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaceutical Co., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2007 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000269
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
