UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005675 |
|---|---|
| Receipt number | R000006710 |
| Scientific Title | Multicenter Clinical Study for Reassessment of Prophylactic Approach of Smoking-related Disease by Smoking Addiction Therapeutic Agent and Establishment and Prevalence of Effective Guide for Smoking Cessation |
| Date of disclosure of the study information | 2011/05/30 |
| Last modified on | 2014/02/12 12:18:37 |
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Basic information
Public title
Multicenter Clinical Study for Reassessment of Prophylactic Approach of Smoking-related Disease by Smoking Addiction Therapeutic Agent and Establishment and Prevalence of Effective Guide for Smoking Cessation
Acronym
NOVA-PGx
Scientific Title
Multicenter Clinical Study for Reassessment of Prophylactic Approach of Smoking-related Disease by Smoking Addiction Therapeutic Agent and Establishment and Prevalence of Effective Guide for Smoking Cessation
Scientific Title:Acronym
NOVA-PGx
Region
| Japan |
Condition
Condition
Nicotine Dependence
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1. Determine the gene-polymorphism involved with nicotine dependence, withdrawal symptom, and adverse reaction during treatment of smoking addiction
2. Establish the adequate program on treatment of smoking addiction by combination of genotype information with pharmacokinetic and pharmacodynamic factors related nicotine dependence
3. Compare the efficacy and safety of valenicline and nicotine replacement therapy in consideration of gene polymorhism involved with nicotin dependence and adverse reaction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between genotype of CYP2A6, drug-metabolizing enzyme involved nicotine dependence, and nicotine dependence
Key secondary outcomes
Relationship between genotype of CYP2A6, drug-metabolizing enzyme involved nicotine dependence, and continuous achievement of smoking cessation or side effect emerged with administration of smoking addiction therapeutic agent
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
People aged 20years old over with smoking and smoking history, and able to receive health insurance treatment
Key exclusion criteria
1. aged under 20years
2. patients who are not able to obtain the informed consent
3. patients who are not expected to complete the research with serious disease
4. patients with history of drug allergy
5. patients received the health insurance treatment of smoking addiction within the past year
6. patients with renal disorder contraindicated to both drugs
7. patients recieved the other no-smoking program, such as online no-smoking advise, no-smoking support in industry, and paid no-smoking support or booklet
8. pregnant or nursing women
9. patients determined to inappropriate for the reseach by investigators
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Azuma |
Organization
Hyogo University of Health Science
Division name
School of Pharmacy
Zip code
Address
1-3-6, Minatojima Chuo-ku, Kobe-shi, Hyogo
TEL
078-304-3143
makikom@huhs.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Maeda |
Organization
Osaka University
Division name
Graduate School of Pharmaceutical Sciences
Zip code
Address
1-6, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-8163
Homepage URL
makikom@phs.osaka-u.ac.jp
Sponsor or person
Institute
Hyogo University of Health Science
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2011 | Year | 05 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2014 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006710
| 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 |
