The purpose of this study is to investigate the efficacy and safety of the ibuprofen suspension, developed by Berlin-Chemie AG for oral administration (20 mg/ml and 40 mg/ml) compared to Nurofen® in reducing fever and pain in children at the age of 3-9 years old with uncomplicated acute otitis media.

• Conditions: Acute otitis media (AOM) is an acute inflammatory disease involving the mucosa of the middle ear. AOM is one of the most frequent complications of upper respiratory tract infections in children. Treatment of AOM requires use of drugs with antipiretic, analgesic and antinflammatory action, as well as antibiotics.; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2015-004077-32-Outside-EU/EEA
• Lead Sponsor: Berlin-Chemie AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-29
• Last Update Posted: 4 January 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1)Child’s parents’ written informed consent for the child’s participation in the study.
2)Boys and girls 3 to 9 years old inclusive.
3)Body weight 10 – 29 kg inclusive.
4)Established diagnosis of AOM, either unilateral or bilateral, following diagnosis criteria:
a)Presence of uni- or bilateral otalgia (pain rating scale score = 4);
b)Recent onset of signs and symptoms including ear pain (within 48 hours);
c)Presence of erythema or fullness or bugling of the tympanic membrane (assessed by otoscopy).
5)Fever = 37.5 º? at screening.
6)Indications for oral antibiotics administration.
7)Parent(s) is(are) able to complete the study protocol (e.g. filling the Diary, assessing ear pain by pain scales) and has(-ve) access to telephone contacts.
Are the trial subjects under 18? yes
Number of subjects for this age range: 135
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

1)Known or suspected hypersensitivity to the ibuprofen or to any of the excipients of study drugs, including fructose intolerance.
2)Known or suspected hypersensitivity to antibiotics (penicillines, cephalosporines, carbapenems).
3)History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
4)Previous treatment of the current AOM:
a)any systemic antibiotic treatment at screening and at least 3 days before screening.
b)any systemic and/or topical analgesics for AOM at screening and within previous 24 hours.
c)previous invasive treatment of current AOM.
5)Severe fever at screening (> 40 °C)
6)Patients requiring non-oral administration of antibiotics.
7)Recurrent AOM (clinical recurrence of AOM within 30 days or history of more than 4 episodes of AOM over the course of 12 months).
8)Presence of otogenic complications of AOM (such as mastoiditis, labyrintitis etc.) or spontaneous perforation of the tympanic membrane.
9)Known presence of complications of the upper respiratory tract infections such as sinusitis (including catarrhal sinusitis) or pneumonia.
10)Known presence of AOM underlying chronic otitis media.
11)Presence of cochlear implants or prior middle ear surgery (e.g., tympanostomy tube[s] in place or a history of tympanostomy tubes).
12)Patients who underwent ear surgery such as canal wall down, mastoidectomy or tympanoplasty less than a year ago.
13)Any form of coagulation disturbances (e.g. hemophilia) or any active bleeding.
14)History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
15)Underlying systemic problems that might obscure response to infection, e.g., serious underlying disease (cystic fibrosis, neoplasm, juvenile diabetes, HIV-infection).
16)Presence of immunodeficiency or receipt of immunosuppressive therapy.
17)Concomitant active infection other than AOM or acute respiratory illness.
18)Known presence of severe hepatic failure (AST, ALT more than 3 times the upper value of the reference range).
19)Known presence of severe renal failure (creatinine clearance < 30 ml/min).
20)Chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease).
21)Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
22)Congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria)
23)Otologic or craniofacial abnormalities (e.g. unrepaired or repaired overt or submucous cleft palate, high-arched palate), or Down's syndrome.
24)Children, who cannot cooperate, comprehend or use the Pain rating scale.
25)The patient requires or may require medications prohibited by the protocol (e.g. ear drops, other NSAIDs and analgesics, systemic corticosteroids, anti-coagulants, CYP2C9 inhibitors, phenylbutazone, oxyphenbutazone, methotrexate and other medications that may interact with study drugs).
26)Participation in another clinical study within previous 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified