An interventional study of Otinova® Ear Spray in Otitis Externa, sponsored by Circius Pharma AB. Terminated at 3 sites in Sweden. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Circius Pharma AB · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
After being informed about the study and potential risks, all patients giving written informed consent will receive treatment with Otinova® Ear Spray for 7 days, twice daily.
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's enrollment of 28 is below the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →This is the only study on the registry with Circius Pharma AB as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of otitis externa based on otoscopic exam:
a.Defined as a clinical score of at least 1, on a scale from 0 to 2 (none, mild/moderate, severe), for at least one of the OE signs (swelling, erythema and otorrhea)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Otinova® Ear Spray 1-2 sprays, twice daily for 7 days
Device: Otinova® Ear Spray
Ear spray
Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea
Proportion of subjects who have all signs of swelling, erythema and otorrhea scored as 0 on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) on Day 7
Time frame: Day 7
Change in Clinical Symptoms Itching, Otalgia and Tenderness
Change in clinical symptoms itching, otalgia and tenderness, from Day 1 to Day 7, based on subject reported outcomes, using a score from 0 to 4, where 0 = no symptoms, 1= Mild, 2 = Moderate, 3= Severe and 4 = Very Severe
Time frame: Change from Baseline (Day 1) to Day 7
Change in Microbes in the Earcanal
Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7.
Time frame: Change from Baseline (Day 1) to Day 7
Change of Moisture in the Earcanal
Proportion of subjects who have signs of otorrhea (moisture) at baseline (Day 1)on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.
Time frame: Change from Baseline (Day 1) to Day 7
Change in Volume of Ear Canal
Proportion of subjects who have signs of swelling at baseline (Day 1) on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.
Time frame: Change from Baseline (Day 1) to Day 7
User Handling
Questionnaire regarding User handling - "How did you experience the use of the earspray?" and "Was it easy to apply the spray correctly in the ear?" using a 5-point scale: 1=very easy to use, 2=easy to use, 3=neither easy nor difficult to use, 4=difficult to use, 5=very difficult to use
Time frame: Day 7
Change in Sleep
Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary
Time frame: Change from Baseline (Day 1) to Day 7
Chnage in Pain Relief Medication Use
Proportion of subjects with less use of pain relief medication for ear pain on Day 7 compared to baseline (Day 1), as reported in subject diary
Time frame: Change from Baseline (Day 1) to Day 7
Antibiotic Use
Use of antibiotics for OE symptoms at Day 7
Time frame: Day 7
| Milestone | Otinova® Ear Spray |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
Proportion of subjects who have all signs of swelling, erythema and otorrhea scored as 0 on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) on Day 7
| Participants | Otinova® Ear Spray |
|---|---|
| Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea | 28 |
Change in clinical symptoms itching, otalgia and tenderness, from Day 1 to Day 7, based on subject reported outcomes, using a score from 0 to 4, where 0 = no symptoms, 1= Mild, 2 = Moderate, 3= Severe and 4 = Very Severe
Results for this outcome have not been posted.
Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7.
Results for this outcome have not been posted.
Proportion of subjects who have signs of otorrhea (moisture) at baseline (Day 1)on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.
Results for this outcome have not been posted.
Proportion of subjects who have signs of swelling at baseline (Day 1) on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.
Results for this outcome have not been posted.
Questionnaire regarding User handling - "How did you experience the use of the earspray?" and "Was it easy to apply the spray correctly in the ear?" using a 5-point scale: 1=very easy to use, 2=easy to use, 3=neither easy nor difficult to use, 4=difficult to use, 5=very difficult to use
Results for this outcome have not been posted.
Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary
Results for this outcome have not been posted.
Proportion of subjects with less use of pain relief medication for ear pain on Day 7 compared to baseline (Day 1), as reported in subject diary
Results for this outcome have not been posted.
Use of antibiotics for OE symptoms at Day 7
Results for this outcome have not been posted.
Collected over 1 year, 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Otinova® Ear Spray | 0/28 (0%) | 0/28 (0%) | 4/28 (14.3%) |
| Event | Otinova® Ear Spray |
|---|---|
| Pain in earEar and labyrinth disorders | 2/28 |
| Pain in armMusculoskeletal and connective tissue disorders | 1/28 |
| Stomach fluGastrointestinal disorders | 1/28 |
| Skin UlcerationSkin and subcutaneous tissue disorders | 1/28 |
| Age, Customized(Participants) | Otinova® Ear Spray |
|---|---|
| 5-17 | 2 |
| >18 | 26 |
| Sex: Female, Male(Participants) | Otinova® Ear Spray |
|---|---|
| Female | 20 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Otinova® Ear Spray |
|---|
| Region of Enrollment(participants) | Otinova® Ear Spray |
|---|---|
| Sweden | 28 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2022 to primary completion in Nov 2023, 18 months.
Results were first posted in Nov 2024, 11 months after primary completion.
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This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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