UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004496
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email fushida@staff.kanazawa-u.ac.jp

Sponsor
Institute NPO Digestive Disease Support Organization (DDSO)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.