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Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001665-33-FI
Enrollment
90
Registered
2012-04-18
Start date
2012-06-14
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis media acuta

Interventions

Trade Name: Amoxin comp 80/11,4mg/ml Product Name: Amoxicillin ratipharm Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 INN or Proposed INN: CL

Sponsors

Päijät-Häme Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Otitis media with drainage from the ventilation tube in children between 1 to 5 years. Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Otherwise sick children.

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparison of different medical treatments for otitis media in ears with a ventilation tube.;Secondary Objective: ;Primary end point(s): Treatment for 6 days.;Timepoint(s) of evaluation of this end point: Between 6-8 days, in working days.

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026