UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031589 |
|---|---|
| Receipt number | R000033555 |
| Scientific Title | A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence |
| Date of disclosure of the study information | 2018/03/14 |
| Last modified on | 2020/07/21 18:03:38 |
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Basic information
Public title
A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Acronym
A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Scientific Title
A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Scientific Title:Acronym
A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Region
| Japan |
Condition
Condition
nicotine dependence
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of CA-F17 in addition to the standard smoking cessation treatment program for nicotine dependence as compared with control application
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
9-24 week Continuous Abstinence Rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
One-time dispense of CA-F17 in conjunction with 3 months of Standard Treatment of Nicotine Dependence
Interventions/Control_2
3 months of Standard Treatment of Nicotine Dependence
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
Cases using a smartphone, diagnosed as nicotine dependent in tobacco dependence screening test who intend to quit smoking immediately
Key exclusion criteria
Cases judged difficult to participate in the trial, such as severe mental illness
Target sample size
580
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tateno |
Organization
Keio University, School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
0333531211
hrk12tateno@me.com
Public contact
Name of contact person
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Muto |
Organization
CureApp, Inc.
Division name
Clinical and Regulatory Affairs Department
Zip code
103-0001
Address
12-5, Kodenmacho, Nihobashi, Chu-o-ku, Tokyo
TEL
03-6231-0183
Homepage URL
clinreg_admin@cureapp.jp
Sponsor or person
Institute
CureApp, Inc.
Institute
Department
Personal name
Funding Source
Organization
CureApp, Inc.
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
Keio University Hospital Institutional Review Board
Address
35 Shinanomachi, Shinjyuku, Tokyo
Tel
0333531211
keio-chiken@adst.keio.ac.jp
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
1 Ankou Medical Clinic Tokyo
2 Ayano Clinic Saitama
3 BOOCS Clinic Fukuoka Fukuoka
4 Chuo Naika Clinic Tokyo
5 Ebisu Garden Place Clinic Tokyo
6 Higashi-hie Naika Fukuoka
7 Hosoda Shinryojo (clinic) Tokyo
8 Inoue Naika Clinic Ibaraki
9 Kanda Clinic Tokyo
10 Keio University Hospital Tokyo
11 Kimura-Shiro Clinic Fukuoka
12 Kita Shin-Yokohama Naika Clinic Kanagawa
13 Mashiba Iin (clinic) Saitama
14 Maekawa Medical Clinic Kanagawa
15 Miyazaki RC Clinic Tokyo
16 Motosumiyoshi Kokoromi Clinic Kanagawa
17 Nakameguro Atlas Clinic Tokyo
18 National Center for Global Health and Medicine Tokyo
19 Nemoto Geka-Seikeigeka (clinic) Saitama
20 Nihonbashi Naika-Allegy Clinic Tokyo
21 Nomura Iin (clinic) Tokyo
22 Odayaka Life Naika Clinic Saitama
23 Saitama City Hospital Saitama
24 Sawayama Naika-Sougoushinryou Clinic Fukuoka
25 Segawa Hospital Saitama
26 Shimizu Clinic Fusa Saitama
27 Shinjuku Research Park Clinic Tokyo
28 Sone Clinic Shinjuku Tokyo
29 Tajima Clinic Tokyo
30 Tenjin Sogo Clinic Fukuoka
31 Ueda Naika Clinic Fukuoka
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2019/2/e12252/
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41746-020-0243-5
Number of participants that the trial has enrolled
584
Results
Continuous abstinence rate from weeks 9 to 24？in the intervention group was significantly higher than that in the control group (63.9% vs. 50.5%; odds ratio [OR], 1.73; 95% confidence interval [CI], 1.24 to 2.42; P？=？0.001).
Results date posted
| 2020 | Year | 07 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 03 | Month | 12 | Day |
Baseline Characteristics
We randomized a total of 584 eligible participants. Of all the participants, 12 did not download or never used either of the apps. Thus, 285 participants allocated to the CASC group and 287 participants assigned to the control group were included in the full analysis set. The participants mean age was 46 years, and 75% were male. The median of the pack years was 20. There were no significant differences in baseline characteristics between the two groups.
Participant flow
Randomization was performed for eligible participants. They were allocated 1:1 to both arms the CASC treatment group and the control app group. Randomization was performed by a computer-generated random sequence with stratification for smoking cessation medications.
Adverse events
In all, 67.4% (192/285) of the CASC group and 63.8% (183/287) of the control had treatment-emergent adverse events, including viral upper respiratory tract infections (20.4% in the intervention group vs. 12.9% in the control), nausea (18.6% vs. 22.3%), influenza (6.0% vs. 3.5%), headache (5.3% vs. 4.2%), constipation (4.9% vs. 5.6%), insomnia (4.6% vs. 2.8%), weight gain (3.9% vs. 2.4%), somnolence (3.5% vs. 5.9%), abdominal discomfort (3.2% vs. 2.1%), and/or contact dermatitis (2.8% vs. 3.1%).
Outcome measures
The primary outcome was the biochemically validated continuous abstinence rate (CAR) from weeks 9 to 24.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 05 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033555
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