N/A N=47 Randomized Trial Comparison of Ototoxicity Monitoring Programs
Cisplatin Ototoxicity · Hearing Loss
Primary: Number of Participants With an Ototoxic Hearing Shift — 15; 8 Participants — p=.27
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=16 Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin
Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Locally Advanced Head and Neck Squamous Cell Carcinoma
Primary: Number of Participants Who Successfully Completed Planned Treatment — 15 Participants
Phase 3 N=39 Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
Ototoxicity · Unspecified Adult Solid Tumor
Primary: Ototoxicity Measurement — 7; 7 participants — p=0.89
Phase 2 N=13 Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Osteosarcoma · Nephrotoxicity · Ototoxicity
Primary: Change in Urinary Biomarkers of Acute Kidney Injury (AKI) Between Pre-Treatment (Baseline), After CISplatin (C) Treatments, and After HDTMX Treatments — 1.7; 1.7; 2.1…
Phase 3 N=131 Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Brain Tumor · Central Nervous System Tumor · Childhood Germ Cell Tumor
Primary: Incidence of Hearing Loss — 14; 31 Patients
Phase 2 N=83 Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Temporary Auditory Threshold Shift
Primary: Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population — 3.23; 1.32; 3.81; 4.07 dbHL — p=<0.05
Phase 2 N=53 Antioxidation Medication for Noise-induced Hearing Loss
Hearing Loss
Primary: Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and…
Phase 2 N=72 Micronutrients to Prevent Noise-induced Hearing Loss
Noise-Induced Hearing Loss
Primary: Average Threshold Shift at 4 kHz in Both Ears — 3.94; 3.4; 2.77; 2.03 decibels — p=0.58
Phase 2 N=43 OTO-313 in Subjects With Subjective Tinnitus
Tinnitus, Subjective
Primary: Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) — -0.3; 0.71; -0.8; 0.3 decibels
N/A N=40 Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer · Dysgeusia · Taste Disorders
Primary: Dysgeusia (UMAMI Perception) — .3; .3 μmol/ml — p=0.013
Phase 2 N=118 Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
Breast Cancer
Primary: Rate of Pathologic Complete Response (pCR) — 0; 0 Participants
Phase 1 N=6 Intratumoral Cisplatin for Resectable NSCLC
Non-Small Cell Lung Cancer
Primary: Rate of Dose Limiting Toxicity — 0 participants
Phase 2 N=95 Dose Ranging Study of OTO-201 in AOMT
Acute Otitis Media · AOMT
Primary: Number of Subjects With Adverse Events — 19; 14; 4 Participants
Phase 2 N=28 Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Sensorineural Hearing Loss
Primary: Safety: Treatment-Emergent Adverse Events (TEAE) — 13; 5 Participants
Phase 2 N=153 OTO-313 in Subjects With Unilateral Subjective Tinnitus
Subjective Tinnitus
Primary: Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 — 20; 27 Participants — p==0.385
Phase 3 N=60 Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Meniere's Disease
Primary: Vertigo Attacks — 16.4; 19.93; 1.6; 2.5 Vertigo Attacks — p=0.271
N/A N=22 Cochlear Promontory Stimulation for Treatment of Tinnitus
Tinnitus
Primary: Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory — -31 score on a scale
Phase 2 N=142 FX-322 in Adults With Acquired Sensorineural Hearing Loss
Hearing Loss, Sensorineural · Noise Induced Hearing Loss · Sudden Hearing Loss
Primary: Word Recognition in Quiet — 14.7; 11.1 Percent of subjects — p=0.525
N/A N=162 Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin
Cancer
Primary: Number of Patients Who Had Complete Response — 50; 42 participants — p=0.41
N/A N=20 Osia CPT Code Study
Conductive Hearing Loss · Mixed Hearing Loss
Primary: Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery — 6.1 Score on a scale
Phase 2 N=75 OTO-201 for the Treatment of Otitis Externa
Otitis Externa
Primary: Otoscopic Examination: Tympanic Membrane — 6; 8; 8 Participants
Phase 2 N=23 FX-322 in Sensorineural Hearing Loss
Sensorineural Hearing Loss
Primary: Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) — 2; 3; 5; 6 Participants
Phase 3 N=255 Sudden Deafness Treatment Trial
Sudden Deafness
Primary: Hearing Improvement — 30.7; 28.7 dB
Phase 2 N=95 FX-322 in Adults With Stable Sensorineural Hearing Loss
Sensorineural Hearing Loss · Noise Induced Hearing Loss · Sudden Sensorineural Hearing Loss
Primary: Word Recognition in Quiet — 23.8; 16.7; 15.8; 18.8 Percent — p=0.068
N/A N=32 Does Sound Conditioning Protect Against Temporary Hearing Damage
Hearing Loss, Noise-Induced
Primary: PTA (EF) — 7.06; 8.94; 7.94; 12.19 dB HL — p=< 0.0005
N/A N=11 Audiovestibular Function in Infratentorial Superficial Siderosis
Siderosis · Neurological Disorder · Rare Diseases
Primary: Hearing Evaluation - Pure Tone Audiometry — 57.3 decibel hearing level
N/A N=129 Hearing Loss Prevention for Veterans
Hearing Loss, Noise-Induced
Primary: Percentage of Time Spent at Sound Levels >80 Decibels — 4.4; 5.0; 6.3 percentage of time — p=0.289
N/A N=6 Vestibular Rehabilitation and Otolith Dysfunction
Dizziness
Primary: Change in Static Subjective Visual Vertical (SVV) — 0.69; 0.58; 0.69; 0.89 degrees — p=0.97
Phase 2 N=147 Cisplatin vs Paclitaxel for Triple Negative Breast Cancer
Triple Negative Breast Cancer
Primary: Number of Participants With Pathologic Response by HR-deficiency (HRD) Status — 9; 2; 10; 4 Participants
Phase 2 N=45 Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer
Bladder Cancer
Primary: Progression Free Survival — 8.2 months