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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004366
Receipt No. R000005220
Scientific Title A randomized controlled trial for local application of insulin-like growth factor 1 using gelatin hydrogels on patients with sudden sensorineural hearing loss
Date of disclosure of the study information 2010/11/30
Last modified on 2014/12/12

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Basic information
Public title A randomized controlled trial for local application of insulin-like growth factor 1 using gelatin hydrogels on patients with sudden sensorineural hearing loss
Acronym A randomized controlled study of local IGF1 treatment for sudden deafness
Scientific Title A randomized controlled trial for local application of insulin-like growth factor 1 using gelatin hydrogels on patients with sudden sensorineural hearing loss
Scientific Title:Acronym A randomized controlled study of local IGF1 treatment for sudden deafness
Region
Japan

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

Objectives
Narrative objectives1 The aim is to examine the efficacy of local IGF1 application using gelatin hydrogels for sudden sensorineural hearing loss.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The primary outcome measure was the proportion of patients showing hearing improvement, which was defined as better than slight recovery according to the following criteria 12 weeks after the treatment. 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 recovery is defined as less recovery than 10 dB in the mean hearing level at the five frequencies tested. In this study, hearing improvement is defined as better than slight recovery according to the criteria described above.
Key secondary outcomes The secondary outcome measures were the proportion of patients showing hearing improvement 16 weeks after the test treatment and the incidence of adverse events during the observation period.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The gelatin hydrogels immersed with an IGF1 solution are placed into the round window niche in the middle ear.
Interventions/Control_2 Intratympanic injections of dexamethasone (four times within seven days)
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 sudden sensorineural hearing loss, (1) who are diagnosed 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 recovery or slight recovery by the criteria for hearing improvement after systemic steroid application for more than seven days, (4) diagnosed within 25 days after the onset, (5) age is 20 years or over, (6) possible to come to outpatient clinic and (7) give their informed consent to participate in the trial.
Key exclusion criteria The exclusion criteria are as follows; (1) presenting active chronic otitis media, acute otitis media, otitis media with effusion or dysfunction of the auditory tube, (2) medicated anti-coagulation drugs, (3) presenting following comorbidities; severe liver dysfunction, uncontrolled diabetes, pituitary or adrenal dysfunction, severe systemic illness with an expected life, (4) presenting following past histories; allergy for gelatin, drugs associated with the treatments in this trial, alcohol or drug dependence within 1 year, (5) presenting malignant tumors, (6) pregnant or lactating women, (7) individuals who are diagnosed as inappropriate for the trial.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Juichi Ito
Organization Graduate School of Medicine, Kyoto University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address Kwaharacho 54, Shogoin, Sakyoku, Kyoto, Japan
TEL 075-751-3346
Email ito@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Nakagawa
Organization Graduate School of Medicine, Kyoto University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address Kawaharacho 54, Shogoin, Sakyoku, Kyoto, Japan
TEL 075-751-3346
Homepage URL
Email tnakagawa@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 京都大学医学部附属病院(京都府)、弘前大学医学部附属病院(青森県)、筑波大学附属病院(茨城県)、虎の門病院(東京都)、信州大学医学部附属病院(長野県)、名古屋市立大学病院(愛知県)、神戸市立医療センター中央市民病院(兵庫県)、愛媛大学医学部附属病院(愛媛県)、九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 30 Day

Related information
URL releasing protocol http://www.kuhp.kyoto-u.ac.jp/~ent/ClinicalTrial/IGF-Random-Trial/IGF-Random-for-MediPro.html
Publication of results Published

Result
URL related to results and publications http://www.biomedcentral.com/1741-7015/12/219
Number of participants that the trial has enrolled
Results
In the IGF-1 group, 66.7% of the patients showed hearing improvement, compared to 53.6% of the patients in the Dex group (P = 0.109). The difference in changes in pure-tone average hearing thresholds over time between the two treatments was statistically significant (P = 0.003). No serious adverse events were observed in either treatment group. Tympanic membrane perforation did not persist in any patient in the IGF-1 group, but did persist in 15.5% of the patients in the Dex group (P = 0.001).
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
2010 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 09 Month 24 Day
Date of closure to data entry
2013 Year 10 Month 14 Day
Date trial data considered complete
2013 Year 10 Month 24 Day
Date analysis concluded
2014 Year 11 Month 19 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 10 Day
Last modified on
2014 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005220

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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