Not provided
Not provided
Not provided
Not provided
Not provided
Slow recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otinova® Ear Spray | Experimental | Otinova® Ear Spray 1-2 sprays, twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otinova® Ear Spray | Device | Ear spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Baseline (Day 1) to Day 7 |
Not provided
Inclusion Criteria:
Male or female ≥ 5 years old
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)
Ability to correctly administer Otinova as spray (not requiring tamponade), as judged by the Investigator
Subject agrees to refrain from water immersion of the ears during the investigation
Subject agrees to refrain from using other ear treatment products during the investigation
For pediatric patients, provision of informed consent by subject and legal -Subject, and if applicable legal representative(s), are willing to comply with the protocol and attend all investigation visits.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Wilhelms, MD, PhD | Cordinator Medical Service AB | Principal Investigator |
| Sarah Ohlsson Maleki, MD | Öron-Näsa-Hals-Center Malmö | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carlanderska sjukhuset | Gothenburg | Sweden | ||||
| Cordinator Medical Service AB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Otinova® Ear Spray | Otinova® Ear Spray 1-2 sprays, twice daily for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Otinova® Ear Spray | Otinova® Ear Spray 1-2 sprays, twice daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Day 7 |
|
|
1 year, 7 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Otinova® Ear Spray | Otinova® Ear Spray 1-2 sprays, twice daily for 7 days | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in ear | Ear and labyrinth disorders | Non-systematic Assessment |
Early termination due to slow recruitment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Carlsson | Circius Pharma AB | +46 (0) 31-81 84 00 | RAQA@circiuspharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2023 | Sep 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2022 | Aug 6, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010032 | Otitis Externa |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in Microbes in the Earcanal |
Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7. |
| 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. | 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. | 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 | Day 7 |
| Change in Sleep | Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary | 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 | Change from Baseline (Day 1) to Day 7 |
| Antibiotic Use | Use of antibiotics for OE symptoms at Day 7 | Day 7 |
| Linköping |
| Sweden |
| Öron-Näsa-Hals-Center Malmö | Malmö | Sweden |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | Not Posted | Change from Baseline (Day 1) to Day 7 | Participants |
| Secondary | Change in Microbes in the Earcanal | Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7. | Not Posted | Change from Baseline (Day 1) to Day 7 | Participants |
| Secondary | 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. | Not Posted | Change from Baseline (Day 1) to Day 7 | Participants |
| Secondary | 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. | Not Posted | Change from Baseline (Day 1) to Day 7 | Participants |
| Secondary | 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 | Not Posted | Day 7 | Participants |
| Secondary | Change in Sleep | Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary | Not Posted | Change from Baseline (Day 1) to Day 7 | Participants |
| Secondary | 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 | Not Posted | Change from Baseline (Day 1) to Day 7 | Participants |
| Secondary | Antibiotic Use | Use of antibiotics for OE symptoms at Day 7 | Not Posted | Day 7 | Participants |
| 28 |
| 0 |
| 28 |
| 4 |
| 28 |
| Pain in arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Stomach flu | Gastrointestinal disorders | Non-systematic Assessment |
|
| Skin Ulceration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided