UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000936 |
|---|---|
| Receipt number | 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 20:25:57 |
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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
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
gel@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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, 15–32) after the onset of SSHL, between 2007 and 2009. At 12 weeks after the test treatment, 48% (95% CI, 28–69%; P = 0.086) of patients showed hearing improvement, and the proportion increased to 56% (95% CI, 35¬–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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001118
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| Registered date | File name |
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