UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020342 |
|---|---|
| Receipt number | R000023500 |
| Scientific Title | Efficacy and safety of cidofovir for recurrent respiratory papillomatosis (1) |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2019/06/28 17:35:57 |
* 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
Efficacy and safety of cidofovir for recurrent respiratory papillomatosis (1)
Acronym
cidofovir for recurrent respiratory papillomatosis (1)
Scientific Title
Efficacy and safety of cidofovir for recurrent respiratory papillomatosis (1)
Scientific Title:Acronym
cidofovir for recurrent respiratory papillomatosis (1)
Region
| Japan |
Condition
Condition
recurrent respiratory papillomatosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of intralesional injection of cidofovir for recurrent respiratory papillomatosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free duration of recurrent respiratory papillomatosis based on Derkay's severity score
Key secondary outcomes
Hematological disorders evaluated by grade od adverse events using CTCAE ver 3.0
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intralesional injection of 3 to 5 mL of 7.5 mg/mL cidofovir under general anesthesia is biweekly performed three times.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with recurrent respiratory papillomatosis who previously received laryngeal surgery
Key exclusion criteria
Patients with severe renal or liver dysfunction, with a risk for general anesthesia, or whom a doctor considered not eligible
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomokazu Yoshizaki |
Organization
Kanazawa University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2413
tomoy@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Nakanishi |
Organization
Kanazawa University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2413
Homepage URL
nakanish@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Otolaryngology-Head and Neck Surgery, Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 12 | Month | 25 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2019 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023500
