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| Name | Class |
|---|---|
| Hangzhou PhecdaMed Co., Ltd. | INDUSTRY |
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The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.
The main purpose of this clinical trial is to explore the safety of TJ0113 capsules in patients with age-related hearing loss; the secondary purpose is to explore the effectiveness; and the exploratory purpose is to exploring changes in muscle strength, depression degree, cognition, and biomarkers after TJ0113 capsule treatment in patients with age-related hearing loss. Approximately 60 subjects (aged from 65~75) will be enrolled in this study according to the randomization and drug randomization tables both of which were generated by computer. The successfully screened subjects were randomly assigned to the 1:1 TJ0113 capsule group (n=30) and placebo group (n=30).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ0113 group | Experimental | Participants will be treated with TJ0113 capsule 200 mg daily for up to 24 weeks |
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| Placebo group | Placebo Comparator | Participants will be treated with a placebo 200 mg daily for up to 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ0113 capsules | Drug | Oral intake on an empty stomach in the morning, 200 mg each time, fasting within half an hour after taking. It is recommended to keep the drug at the same time (± 1 h ) of a day . |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of TJ0113 capsule in the treatment of patients with age-related hearing loss | Incidence of adverse events in each group | Baseline, weeks 1, 4, 12, 24, and 1 week after discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility - Word Recognition in Quiet and Noise | To compare the change in word list-measured recognition accuracy rates for words and short sentences in both quiet and noise. | From baseline to 4, 12 ,24 weeks |
| Pure Tone Audiometry (PTA) |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory brainstem response (ABR) | To compare the change in the auditory brainstem response (ABR) using the threshold (dB). Higher thresholds indicate worse outcomes. | From baseline to 12 and 24 weeks |
| Distortion product otoacoustic emissions (DPOAE) |
Inclusion Criteria:
Exclusion Criteria:
7.Failure to swallow oral medication, or, according to the investigator, any conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or that may pose a hazard to the subjects participating in this trial; 9.People who currently taking drugs that can improve symptoms such as dementia and depression 10.Subjects with a severe or unstable systemic disease, such as serious congenital disease, blood disease, endocrine disease, nerve or nervous system disease, end-stage disease, head and neck tumor radiotherapy and chemotherapy history, major surgical treatment, psychological disorders (severe insomnia, severe depression, severe anxiety, etc. diagnosed within the previous 90 days ) or history and clinical significance of abnormal baseline laboratory values, such as hepatic insufficiency (alanine transaminase (ALT) and / or alanine transaminase (AST) is 2 times above the upper limit of the reference range, or renal insufficiency (creatinine clearance Ccr <30 mL/min), or history of malignant tumors and the detection results of tumor markers during the screening period have clinical significance, or unsuitable participants, as judged by the investigator; 11.Subjects suffering from any one of the following heart diseases: a. having uncontrolled or serious cardiovascular and cerebrovascular disease, including the development of grade II ( New York Heart Association, NYHA) or above congestive heart failure, unstable angina, acute myocardial infarction within 6 months before the first drug administration, or cardiac arrhythmias requiring treatment at screening; With b. hypertension (systolic pressure≥ 160mmHg and / or diastolic v≥ 100mmHg), and after the combination of two or more antihypertensive drugs can not be reduced to the normal range; or c.with a history of clinically significant ECG abnormalities, the QRS time was> 120ms, Long QT syndrome: QTc interval> 450ms in male or QTc interval> 470ms in female.
12.Participated in a clinical study involving the administration, device, or surgery of the study drug (new chemical entity) within 90 days or 5 half-lives (whichever is longer) 13.Patients with a previous history of hepatitis B, or any of the following indicators are positive at screening: hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.
14.The subject is not fit to participate in the study if the investigator considers. Or the subject could not participate in the trial for his own reasons, or the behavior subject may interfere with treatment, study or interpretation of results (e. g., previous treatment with high-dose aminoglycosides).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D011304 | Presbycusis |
| D003638 | Deafness |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
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| Placebo capsules | Drug | Oral intake on an empty stomach in the morning, 200 mg each time, fasting within half an hour after taking. It is recommended to keep the drug at the same time (± 1 h ) of a day . |
|
To ompare the change in Pure Tone Audiometry (PTA) using the air and bone conduction audiometry for hearing at certain range (Hz).
| From baseline to 4, 12 ,24 weeks |
| Individual's health-related quality of life (HRQOL) | SF-36 quality of life questionnaire will be measured to compare the change in individual's health-related quality of life using face to face Interview for the scores. Higher scores mean better functioning or fewer symptoms. | From baseline to 4, 12 ,24 weeks |
To compare the changes in the pass rate levels of distortion product otoacoustic emissions(DPOAE).
| From baseline to 12 and 24 weeks |
| Tinnitus Assessment | Tinnitus Handicap Inventory (THI) questionnaire scores will be measrued to compare the change in tinnitus using face to face Interview for the scores. Higher scores indicate worse outcomes. | From baseline to 4, 12 and 24 weeks |
| Muscle strength | To compare the change in the muscle strength (kg) measured with a handgrip dynamometer. | From baseline to 4, 12 and 24 weeks |
| Depression levels | To compare the change in depression levels using face to face Interview for the Geriatric depression scale-15 (GDS-15) scores. | From baseline to 4, 12 and 24 weeks |
| Cognition | To compare the change in cognition by Montreal cognitive gssessment (MoCA) using face to face Interview for the scores. | From baseline to 4, 12 and 24 weeks |
| Plasma Senescence-associated secretory factor (SASP) | The absolute values of changes in the levels of plasma Senescence-associated secretory factor (SASP) related to the mechanism. The concentration of the plasma Senescence-associated secretory factor will be measured. | From baseline to 24 weeks |
| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |