UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004496 |
|---|---|
| Receipt number | R000005109 |
| Scientific Title | A randomized phase II study of perioperable tiotropium treatment in gastric cancer patient with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2010/11/02 |
| Last modified on | 2013/11/05 11:56:31 |
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Basic information
Public title
A randomized phase II study of perioperable tiotropium treatment in gastric cancer patient with chronic obstructive pulmonary disease
Acronym
A randomized phase II study of tiotropium in gastric cancer with COPD
Scientific Title
A randomized phase II study of perioperable tiotropium treatment in gastric cancer patient with chronic obstructive pulmonary disease
Scientific Title:Acronym
A randomized phase II study of tiotropium in gastric cancer with COPD
Region
| Japan |
Condition
Condition
gastric cancer patient with COPD
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy and safety of perioperative tiotropium treatment for gastric cancer patients with COPD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reduction of FEV1.0 on POD14
Key secondary outcomes
pulmonaly mobidity rate, the number of days for O2 support after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
preoperative tiotropium for over 1 week and postoperative tiotropium for 2 weeks
Interventions/Control_2
Inharation of bromhexine/tyloxapol after surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histopathologically confirmed gastric cancer.
2) COPD patient, COPD stage I/II
3) no severe heart failure and arrithmia
4) preoperative day > 2 weeks
5) age of 20 years or older
6) Written informed consent
Key exclusion criteria
1) glaucoma
2) dysuria dur to BPH
3) allergy for atropine and tiotropium
4) Patient is diagnosis as asthma
5) clinically important infection or acute inflammation
6) psychological disease
7) patients who are judged to be ineligible by principal investigator for any other reason
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujimura |
Organization
Kanazawa University Hospital
Division name
Gastroenterologic Surgery
Zip code
Address
13-1 Takara-machi, Kanazwa
TEL
076-265-2362
tphuji@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachio Fushida |
Organization
Kanazawa University Hospital
Division name
Gastroenterologic Surgery
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2362
Homepage URL
fushida@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
NPO Digestive Disease Support Organization (DDSO)
Institute
Department
Personal name
Funding Source
Organization
NPO Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2010 | Year | 11 | Month | 02 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 02 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005109
| 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 |
