Pharyngotonsillitis
Conditions
Brief summary
The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.
Detailed description
The total duration of the study period per patient is 10 ± 1 day
Interventions
DRUGKetoprofen
Formulation: oral solution 20mg/mL Route of administration: oral Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d
DRUGPlacebo (for Ketoprofen)
Formulation: oral solution Route of administration: oral Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d
DRUGAmoxicillin
Formulation: suspension 125mg/5 mL Route of administration: oral Dose regimen: 20-40mg/Kg/day administered t.i.d
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Quick-test positive for Streptococcus pyogenes; * Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation; * Pain (for swallowing) evaluated by Wong Baker Faces Pain scale with at least grade 3; * Presence of at least two of the follow symptoms: * Hyperemia and edema evaluated with at least 2 out of 4 crosses * Fever in the previous 48 hours * Cervical adenomegaly * Tonsilla with erythema or erythema and white exsudate.
Exclusion criteria
* History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions; * History and laboratorial confirmation of hematologic, hepatic or renal disorders; * Use of nonsteroidal antiinflammatory drugs (NSAID) during the last 3 weeks and gastroesophageal reflux during the last 6 months; * Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours; * History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment | 72 hours |
| Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication | 24 hours and 72 hours |
| Number of patients who used rescue medication after randomization. | 72 hours |
Countries
Brazil
Outcome results
None listed