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

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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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name