TinnitusPhase 3NCT04210310
High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
A Phase 3 study testing Oxytocin in people with Tinnitus, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 10 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health
New York, New York, 10017
About this study
Official title: A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus
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.
Read the detailed description
This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's Ear, Nose \& Throat (ENT) Department and will receive either high-dose intranasal oxytocin or a nasal spray containing Pcca Mucolox and distilled water, serving as the placebo. Long term treatment with high-dose oxytocin (45 IU four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
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
Placebo nasal sprayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| high-dose intranasal oxytocin | Experimental | 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. Receives: Drug: Oxytocin |
| Nasal spray | Placebo comparator | 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. Receives: Other: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
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.
Measured: Baseline, Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start15 Jan 2020
- Primary completion10 May 2022
- Study completion10 May 2022
Why it stopped: PI departure from the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Newman, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210310
- Sponsor's protocol ID
- 19-01381
- Status last verified
- Sep 2022
- First submitted
- 12 Dec 2019
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT04210310
- Acronym / sponsor ID
- 19-01381
- Conditions
- Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI departure from the institution.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 5 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's Ear, Nose \& Throat (ENT) Department and will receive either high-dose intranasal oxytocin or a nasal spray containing Pcca Mucolox and distilled water, serving as the placebo. Long term treatment with high-dose oxytocin (45 IU four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-dose intranasal oxytocin | Experimental | Drug: 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. |
| Nasal spray | Placebo comparator | Other: Placebo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: PitocinThe 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 | Drug | high-dose intranasal oxytocin |
| Placebo nasal sprayA 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. | Other | Nasal spray |
Primary outcome
Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
Time frame: Baseline, Week 9
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Newman, MD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxytocin in people with Tinnitus, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness (time frame: Baseline, Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.