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NCT04210310
High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
Phase 3 trial testing Oxytocin in Tinnitus in 33 participants. Terminated before completion.
10 May 2022
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 15 January 2020 |
| Primary completion | 10 May 2022 |
| Estimated completion | 10 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Oxytocin (OXYTOCIN) — full drug profile →
- Placebo nasal spray — full drug profile →
Conditions studied
- Tinnitus — all drugs for Tinnitus →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 18 to 75, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (1 terms)
| Reaction | System | High-dose Intranasal Oxyto… | Nasal Spray |
|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
Other adverse events (7 terms — click to expand)
| Reaction | System | High-dose Intranasal Oxyto… | Nasal Spray |
|---|---|---|---|
| Mild Nasal Congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Atypical, intermittent chest pain | Cardiac disorders | — | — |
| Mild Headache | Nervous system disorders | — | — |
| Intermittent Dizziness | Nervous system disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Increased urination | Renal and urinary disorders | — | — |
Most-reported serious reactions: Dyspnea.
Data from ClinicalTrials.gov NCT04210310 adverse events section.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04210310
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Tinnitus
Currently open trials in the same condition.
- NCT07393880 — Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus · NA · recruiting
- NCT07071480 — Noninvasive Therapy for Tinnitus · NA · recruiting
- NCT07435298 — Navigated Repetitive TMS for Chronic Tinnitus · NA · recruiting
- NCT07158034 — Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation · NA · recruiting
- NCT07017998 — External Therapy for Tinnitus Management · NA · recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
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- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04210310 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 5 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04210310.
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