UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015337 |
|---|---|
| Receipt number | R000017834 |
| Scientific Title | Treatment of vocal fold scar with KP-100LI: phase I/II clinical trial |
| Date of disclosure of the study information | 2014/10/03 |
| Last modified on | 2017/07/24 19:59:48 |
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Basic information
Public title
Treatment of vocal fold scar with KP-100LI: phase I/II clinical trial
Acronym
KP-100LI for vocal scar
Scientific Title
Treatment of vocal fold scar with KP-100LI: phase I/II clinical trial
Scientific Title:Acronym
KP-100LI for vocal scar
Region
| Japan |
Condition
Condition
Vocal fold scar, sulcus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore safty aspect and vocal outcome by local application of KP-100LI to vocal fold scar and sulcus
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safty aspect for KP-100LI
Key secondary outcomes
Therapeutic effect in VHI-10, Jitter, MPT, GRBAS, NMWA
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transoral application of KP-100LI to the vocal fold
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis of vocal fold scar or suclus by stroboscopic exmaination
No orgnic or neurologic disorder on the vocal fold
More than 11 scor of VHI-10
Key exclusion criteria
Airway disease caused by burn
History of malignant diseases
Pregnant woman
Severe systemic diseases
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Hirano |
Organization
Kyoto University Hospital
Division name
Otolaryngology
Zip code
Address
Sakyo-ku, Kyoto 606-8507
TEL
075-751-3731
hirano@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Hirano |
Organization
Kyoto University Hospital
Division name
Otolaryngology
Zip code
Address
Sakyo-ku, Kyoto 606-8507
TEL
075-751-3731
Homepage URL
hirano@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health and Welfare
Organization
Division
Category of Funding 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
| 2014 | Year | 10 | Month | 03 | 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
| 2014 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 04 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 04 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 03 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017834
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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