UMIN-CTR Clinical Trial

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

Sudden sensorineural hearing loss

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medicine, Kyoto University

Institute

Department

Personal name

Organization

Japanese Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

11

Month

30

Day

URL releasing protocol

http://www.kuhp.kyoto-u.ac.jp/~ent/ClinicalTrial/IGF-Random-Trial/IGF-Random-for-MediPro.html

Publication of results

Published

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

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 related information

Registered date

2010

Year

10

Month

10

Day

Last modified on

2014

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005220