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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000936
Receipt No. R000001118
Scientific Title Phase I-II study for therapeutic efficacy of local recombinant human local insulin like growth factor 1 treatment via biodegradable gelatin hydrogels for acute sensorineural hearing loss
Date of disclosure of the study information 2007/12/12
Last modified on 2010/11/25

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Basic information
Public title Phase I-II study for therapeutic efficacy of local recombinant human local insulin like growth factor 1 treatment via biodegradable gelatin hydrogels for acute sensorineural hearing loss
Acronym Clinical trial of local IGF1 treatment for acute sensorineural hearing loss
Scientific Title Phase I-II study for therapeutic efficacy of local recombinant human local insulin like growth factor 1 treatment via biodegradable gelatin hydrogels for acute sensorineural hearing loss
Scientific Title:Acronym Clinical trial of local IGF1 treatment for acute sensorineural hearing loss
Region
Japan

Condition
Condition acute sensorineural hearing loss
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the safety and efficacy of local recombinant human IGF1 application through the round window membrane using biodegradable gelatin hydrogels for patients with acute sensorineural hearing loss.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes The therapeutic effects are evaluated 12 weeks after the treatment, using pure tone audiometry. The criteria for hearing improvement, which was determined by the sudden deafness research committee of the Japanese Ministry of Health, Labour and Welfare in 1984, is used in this study. Complete recovery is defined as recovery of a hearing level within 20 dB at all five frequencies tested: 0.25, 0.5, 1.0, 2.0 and 4.0 kHz or recovery to the same level as the opposite side. Marked recovery is defined as more than 30 dB recovery in the mean hearing level at the five frequencies tested. Slight recovery is defined as recovery of 10-29 dB in the mean hearing level at the five frequencies tested. No response is defined as less recovery than 10 dB in the mean hearing level at the five frequencies tested.
Key secondary outcomes Key secondary outcomes are included the ratio of the emergence of adverse events, and the gain of hearing levels of the pure-tone average (0.25, 0.5, 1, 2, 4 kHz) 12 or 24 weeks after the treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The registration period for this study is from December 17, 2007 to September 3, 2009. The observation period for the patients is 24 weeks. Biodegradable gelatin hydrogels are made from gelatin in a clean room at the department of Pharmacy, Kyoto University Hospital. Mecasermin (recombinant human IGF1, Somazon 10mg for injection, Astellas Pharma Inc, Tokyo, Japan) is dissolved in physiological saline, and the final concentration is 10mg/mL. A 30ul of Mecasermin solution is mixed with 3mg biodegradable hydrogels 60min before application. The hydrogel containing 300ug Mecasermin is placed in the round window niche in the middle ear. In the current study, a single application is used.
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

Not applicable
Gender Male and Female
Key inclusion criteria Subjects are patients with acute sensorineural hearing loss, (1) who arediagnosed as definite or probable for the criteria for the diagnosis of idiopathic sudden sensorineural hearing loss (determined by the sudden deafness research committee of the Japanese Ministry of Health, Labour and Welfare in 1973). Subjects satisfy the following conditions; (2) presenting the abnormality in evoked otoacoustic emission, (3) determined as no response by the criteria for hearing improvement after systemic steroid application, (4) diagnosed within 29 days after the onset of hearing loss, (5) age is 20 years or over, (6) possible to come to outpatient clinic of Kyoto University Hospital and (7) give their informed consent to participate in the trial.
Key exclusion criteria The exclusion criteria are as follows; (1) presenting active chronic otittis media, acute otittis media, otittis media with effusion or dysfunction of the auditory tube, (2) history of previous other treatments including systemic application of batroxobin, progtagrandin I, and hyper oxygen therapy, except for systemic steroid application, (3) presenting malignant tumors, (4) presenting severe liver dysfunction (AST>100, ALT >100), (5) presenting uncontrolled diabetes (HbA1c>10), (6) presenting pituitary or adrenal dysfunction, (7)severe systemic illness with an expected life expectancy, (8) pregnant or lactating women, (9) history of drug allergy, (10) treated with batroxobin or prostagrandin E1or I after the onset of hearing loss, (11) past history of alcohol or drug dependence within 1 year, (12) individuals who are diagnosed as inappropriate for the trial (ie: difficulty in a 24-week follow up).
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Juichi Ito
Organization Kyoto University Graduate School of Medicine
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address Kawaharacho 54, Shogoin, Sakyoku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Nakagawa
Organization Kyoto University Hospital
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address
TEL
Homepage URL
Email gel@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2007 Year 12 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.biomedcentral.com/content/pdf/1741-7015-8-76.pdf
Number of participants that the trial has enrolled
Results
In total, 25 patients received the test treatment at a median of 23 days (range, 15&#8211;32) after the onset of SSHL, between 2007 and 2009. At 12 weeks after the test treatment, 48% (95% CI, 28&#8211;69%; P = 0.086) of patients showed hearing improvement, and the proportion increased to 56% (95% CI, 35&not;&#8211;76%; P = 0.015) at 24 weeks. No serious adverse events were observed.
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
2007 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
2010 Year 02 Month 01 Day
Date trial data considered complete
2010 Year 02 Month 01 Day
Date analysis concluded
2010 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 06 Day
Last modified on
2010 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001118

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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