Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
219
Countries
1
Sites
3
Acute otitis media
The main objective is to compare amoxicillin to placebo and amoxicillin-clavulanate in the treatment of acute otitis media in children.
Key facts
- Sponsor
- Pohjois-Savon hyvinvointialue
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2026-02-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective is to compare amoxicillin to placebo and amoxicillin-clavulanate in the treatment of acute otitis media in children.
Conditions and MedDRA coding
Acute otitis media
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age 6-35 months and diagnosis of AOM along the prespecified criteria
Exclusion criteria 1
- - complicated AOM , spontaneous perforation of the tympanic membrane, known allergy to aminopenicillins, antibiotic treatment for another infectious disease, present or during 2 preceding weeks, tympanostomy tube or chronic perforation of the tympanic membrane, anatomic defect or anomaly affecting the susceptibility to AOM, immune defect, either primary or secondary, severe chronic kidney disease, known hearing defect
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome is condition of the child, measured daily in days 1-7 and at days 10 and 14 with AOM-SOS score version 6.0. The treatment effectiveness measured as risk ratios and generalized estimation equations (GEE) are used to convert the daily mean comparisons into relative effect estimates
Secondary endpoints 1
- Secondary outcomes are proportions of children - needing rescue antibiotics - with no improvement of overall condition by the first scheduled control visit (day 2-4) - with no improvement of otoscopic signs (7-9 day visit) - with middle ear effusion at days 2, 7 and 14 - with development of contralateral AOM during the treatment - with spontaneous perforation of the tympanic membrane during the treatment - with side effects (for ex. diarrhea, rash)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Amorion 100 mg/ml jauhe oraalisuspensiota varten
PRD11808814 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 50 mg/kg milligram(s)/kilogram
- Max total dose
- 350 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- 16734
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Amorion Comp 80 mg/ml jauhe oraalisuspensiota varten
PRD11809647 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 80 mg/kg milligram(s)/kilogram
- Max total dose
- 560 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 24781
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product is put in a brown glass bottle and 85 ml of purified water is added to the bottle to get a mixture with a concentration of 89mg/ml and to be able to maintain masking (the added amount of water equal in all products). This gives an ideal dosage of 40-50mg/kg/day along to our dosage table to all participants.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pohjois-Savon hyvinvointialue
- Sponsor organisation
- Pohjois-Savon hyvinvointialue
- Address
- Puijonlaaksontie 2, P. O. Box 1711 P. O. Box 1711
- City
- Kuopio
- Postcode
- 70211
- Country
- Finland
Scientific contact point
- Organisation
- Pohjois-Savon hyvinvointialue
- Contact name
- Marjo Helena Renko
Public contact point
- Organisation
- Pohjois-Savon hyvinvointialue
- Contact name
- Marjo Helena Renko
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 219 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | DI Protocol 2025-524259-30-00 signed | 1 |
| Recruitment arrangements (for publication) | informed_consent_patient_recruitment_procedure_2025-524259-30-00 | 1 |
| Recruitment arrangements (for publication) | recruitment and informed consent | 1 |
| Subject information and informed consent form (for publication) | SAVOtitis lyhyt tiedote potilaalle suomeksi versio 2 170226 | 2 |
| Subject information and informed consent form (for publication) | Suostumus SAVOtitis trial versio 2 151025 | 1 |
| Subject information and informed consent form (for publication) | Suostumus vaiheet 1 ja 2 SAVOtitis trial versio 4 170226 | 4 |
| Subject information and informed consent form (for publication) | Tutkittavan tiedote SAVOtitis trial_versio 2 | 1 |
| Subject information and informed consent form (for publication) | Tutkittavan tiedote SAVOtitis trial_versio 4 170226 | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-17 | Finland | Acceptable 2026-02-16
|
2026-02-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-19 | Finland | Acceptable 2026-02-16
|
2026-02-19 |