NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041180032

Registered date:29/01/2019

Cidofovir for laryngeal papillomatosis

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedrecurrent respiratory papillomatosis
Date of first enrollment15/10/2014
Target sample size20
Countries of recruitmentNot applicable,Japan
Study typeInterventional
Intervention(s)1.Evaluation of the general condition including renal function before operation. 2.Local injection to the laryngeal papillomatosis under general anesthesia third times every two weeks. 3.Single therapy, the resection and local injection of the cidofovir, can be performed when the recurrent resion was found after 3 months from the third time injection of cidofovir. 4.At first, single therapy can be performed to the patient has been administerd the cidofovir in the other clinical trial.

Outcome(s)

Primary OutcomeTime to progression
Secondary OutcomeThe safety of intralesional cidofovir injection, response rate to cidofovir

Key inclusion & exclusion criteria

Age minimum>= 16age old
Age maximumNot applicable
GenderBoth
Include criteria1. Laryngeal papillomatosis diagnosed by laryngeal fiber scope and histopathological examination. 2. Adequate organ function: 1) White blood cells > 2,500/mm3 2) Neutrophils > 1,250/mm3 3) Platelet > 75,000/mm3 4) GOT < 100 IU/L, ALT < 100IU/L 5) Serum creatinine < 1.5 mg/dL 3. Written informed consent
Exclude criteria1.Renal dysfunction: serum createnin more than 1.5 mg/dL 2.Nephrotoxic drug administration 3.An allergy to cidofovir 4.An allergy to probenecid or sulfa drug 5.Pregnant, unwilling to practice contraception during the study, or lactating female 6.Inappropriate decided by doctor

Related Information

Contact

Public contact
Name Yosuke NAKANISHI
Address Takaramachi13-1,Kanazawa-shi,Ishikawa Ishikawa Japan 920-8640
Telephone +81-76-265-5212
E-mail nakanish@med.kanazawa-u.ac.jp
Affiliation Kanazawa University
Scientific contact
Name Tomokazu YOSHIZAKI
Address Takaramachi13-1,Kanazawa-shi,Ishikawa Ishikawa Japan 920-8640
Telephone +81-76-265-2410
E-mail tomoy@med.kanazawa-u.ac.jp
Affiliation Kanazawa University