Trial Outcomes & Findings for High Dose Oxytocin Nasal Spray for Treatment of Tinnitus (NCT NCT04210310)
NCT ID: NCT04210310
Last Updated: 2022-10-05
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Baseline, Week 9
Results posted on
2022-10-05
Participant Flow
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.
Participant milestones
| Measure |
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.
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
|
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.
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 Study
STARTED
|
32
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
1
|
Reasons for withdrawal
| Measure |
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.
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
|
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.
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 Study
Lost to Follow-up
|
32
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High-dose Intranasal Oxytocin
n=32 Participants
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
|
Nasal Spray
n=1 Participants
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
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 11.5 • n=32 Participants
|
66 years
STANDARD_DEVIATION 0 • n=1 Participants
|
60.1 years
STANDARD_DEVIATION 11.3 • n=33 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=32 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=32 Participants
|
1 Participants
n=1 Participants
|
28 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
1 participants
n=1 Participants
|
33 participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 9Population: Study was terminated prematurely due to PI and study team departing the institution. Data were not collected for the primary outcome measure.
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.
Outcome measures
Outcome data not reported
Adverse Events
High-dose Intranasal Oxytocin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Nasal Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-dose Intranasal Oxytocin
n=32 participants at risk
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
|
Nasal Spray
n=1 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
Other adverse events
| Measure |
High-dose Intranasal Oxytocin
n=32 participants at risk
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
|
Nasal Spray
n=1 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mild Nasal Congestion
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
|
Cardiac disorders
Atypical, intermittent chest pain
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
|
Nervous system disorders
Mild Headache
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
|
Nervous system disorders
Intermittent Dizziness
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
|
Renal and urinary disorders
Increased urination
|
3.1%
1/32 • 6 Weeks
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.
|
0.00%
0/1 • 6 Weeks
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.
|
Additional Information
Lawrence Newman, MD
NYU Langone Health - Preston Robert Tisch Center for Men's Health
Phone: 646-754-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place