High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
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|ClinicalTrials.gov Identifier: NCT04210310|
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : January 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Drug: Oxytocin Other: Placebo nasal spray||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: high-dose intranasal oxytocin
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.
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
Other Name: Pitocin
Placebo Comparator: Nasal spray
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.
Other: Placebo nasal spray
The placebo nasal spray consists of distilled water. 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.
- Change of tinnitus loudness as measured by Visual Analogue Scale (VAS) when compared to placebo [ Time Frame: Visit Week 4 (8 wks) ]Comparing endpoints of Visual Analogue Scale (VAS) of all 30 subjects at 4th week of treatment with active drug vs baseline. The primary outcome measure for this study will be a greater than 50% improvement in tinnitus loudness on the Visual Analog Scale (VAS). No response to nasal spray is defined as a decrease in VAS < 2, and a patient reported improvement is defined as an increase in VAS > 3. No minimum and maximum values are defined.The higher the score indicates more improvement in tinnitus loudness.
- Comparative change of tinnitus loudness of same subjects given placebo vs active drug [ Time Frame: Visit Week 5 (8 wks) , Visit Week 9 (16wks) ]Comparative endpoint during the cross-over phase of VAS at the 4th week between the 15 subjects who received placebo vs the 4th week of the single blinded phase for the same subjects . This endpoint compares the 15 patients that were switched from active to placebo and compares their response on placebo with their response on placebo and compare them to the 15 subjects that remained on active drug during the entire study.
- Comparative change in tinnitus loudness using active drug alone or active drug and placebo [ Time Frame: Visits Week 5 (8 wks), Week 6 (10wks), Week 7 (12wks), Week 8 (14wks), Week 9 (16 wks) ]A parallel group analysis to compare both arms in the last week of the double-blind phase—comparing those 15 who were on active throughout the entire study to those that started on active and changed over to placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04210310
|Contact: Lawrence Newman, MD||646 754-2000||Lawrence.Newman@NYUlangone.org|
|Contact: Jacqueline Okolie||646 754-2000||Jacqueline.Okolie@nyulangone.org|
|United States, New York|
|222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health||Recruiting|
|New York, New York, United States, 10017|
|Principal Investigator:||Lawrence Newman, MD||NYU Langone|