Trial · Interventional

TerminatedPhase 3Results postedRegistry data

High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

NCTNCT04210310Other id19-01381

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: PI departure from the institution.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 33 participants (actual)
Sponsor: NYU Langone Health · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 15 Jan 2020
Primary completion: 10 May 2022
Completion: 10 May 2022
First posted: 24 Dec 2019
Last update posted: 5 Oct 2022
Conditions: Tinnitus

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202120222023

Ph 3
High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
NCT04210310
15 Jan 2020 to 10 May 2022
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.

Interventions

OxytocinDrug
Placebo nasal sprayOther

Arms2

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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
Time frame · Baseline, Week 9
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Baseline, Week 9

Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness

Group	Value
High-dose Intranasal Oxytocin	not posted
Nasal Spray	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
High-dose Intranasal OxytocinSubjects 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	0 / 32	1 / 32	6 / 32
Nasal SpraySubjects 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.	0 / 1	0 / 1	0 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration. * Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of \> 16. * Subjects must have tinnitus loudness rating of \>4/10. Exclusion Criteria: * Subjects who are being treated for tinnitus \< 6 months due to the acute nature of their condition * Subjects who have a slight handicap according to the Tinnitus Handicap Inventory Severity Scale. * Those with tinnitus of a muscular or vascular etiology * Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray. * Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions. * Subjects who suffer from migraines. * Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.

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