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High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04210310
Recruitment Status : Terminated (PI departure from the institution.)
First Posted : December 24, 2019
Results First Posted : October 5, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Drug: Oxytocin
Other: Placebo nasal spray
Enrollment 33
Recruitment Details  
Pre-assignment Details The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Arm/Group Title High-dose Intranasal Oxytocin Nasal Spray
Hide Arm/Group Description

Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.

Oxytocin: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day

Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.

Placebo nasal spray: A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.

Period Title: Overall Study
Started 32 1
Completed 0 0
Not Completed 32 1
Reason Not Completed
Lost to Follow-up             32             1
Arm/Group Title High-dose Intranasal Oxytocin Nasal Spray Total
Hide Arm/Group Description

Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.

Oxytocin: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day

Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.

Placebo nasal spray: A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.

Total of all reporting groups
Overall Number of Baseline Participants 32 1 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 1 participants 33 participants
59.9  (11.5) 66  (0) 60.1  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 1 participants 33 participants
Female
5
  15.6%
0
   0.0%
5
  15.2%
Male
27
  84.4%
1
 100.0%
28
  84.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 1 participants 33 participants
32 1 33
1.Primary Outcome
Title Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
Hide Description

Participants use a VAS to rate the loudness of tinnitus on an 11-point Likert scale. Total scores range from 0 (minimum) to 10 (maximum); higher scores indicate greater tinnitus loudness.

No response to nasal spray is defined as a decrease in VAS Score of less than 2, while a patient-reported improvement is defined as a decrease in VAS Score of more than 3.

Time Frame Baseline, Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated prematurely due to PI and study team departing the institution. Data were not collected for the primary outcome measure.
Arm/Group Title High-dose Intranasal Oxytocin Nasal Spray
Hide Arm/Group Description:

Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.

Oxytocin: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day

Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.

Placebo nasal spray: A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 Weeks
Adverse Event Reporting Description Every other week, participants will receive a phone call from study staff to discuss their experience using the study drug and monitor for any adverse effects.
 
Arm/Group Title High-dose Intranasal Oxytocin Nasal Spray
Hide Arm/Group Description

Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.

Oxytocin: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day

Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.

Placebo nasal spray: A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.

All-Cause Mortality
High-dose Intranasal Oxytocin Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
High-dose Intranasal Oxytocin Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   1/32 (3.13%)   0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea   1/32 (3.13%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High-dose Intranasal Oxytocin Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   6/32 (18.75%)   0/1 (0.00%) 
Cardiac disorders     
Atypical, intermittent chest pain   1/32 (3.13%)  0/1 (0.00%) 
Gastrointestinal disorders     
Diarrhea   1/32 (3.13%)  0/1 (0.00%) 
Infections and infestations     
Bronchitis   1/32 (3.13%)  0/1 (0.00%) 
Nervous system disorders     
Mild Headache   1/32 (3.13%)  0/1 (0.00%) 
Intermittent Dizziness   1/32 (3.13%)  0/1 (0.00%) 
Renal and urinary disorders     
Increased urination   1/32 (3.13%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Mild Nasal Congestion   1/32 (3.13%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
Study was prematurely terminated due to PI/Study Team departure from institution. No outcome measure data collected or analyzed. All participants lost to follow-up.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lawrence Newman, MD
Organization: NYU Langone Health - Preston Robert Tisch Center for Men's Health
Phone: 646-754-2000
EMail: Lawrence.Newman@nyulangone.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04210310    
Other Study ID Numbers: 19-01381
First Submitted: December 12, 2019
First Posted: December 24, 2019
Results First Submitted: August 4, 2022
Results First Posted: October 5, 2022
Last Update Posted: October 5, 2022