Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients
NCT ID: NCT00799838
Last Updated: 2014-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
106 participants
INTERVENTIONAL
2008-11-30
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TELI TON - Telithromycin in Tonsillitis
NCT00315042
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
NCT00393744
Bacteriological Study of Acute Follicular Tonsillitis
NCT04321733
L. Reuteri ATCC PTA 5289 & L. Reuteri DSM 17938 for the Treatment of Children With Pharyngitis and/or Tonsillitis
NCT03377374
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
NCT01404611
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ketoprofen + Amoxicillin
Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Ketoprofen
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
Amoxicillin
Formulation: suspension 125mg/5 mL
Route of administration: oral
Dose regimen: 20-40mg/Kg/day administered t.i.d
Amoxicillin
Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Placebo (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
Amoxicillin
Formulation: suspension 125mg/5 mL
Route of administration: oral
Dose regimen: 20-40mg/Kg/day administered t.i.d
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ketoprofen
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
Placebo (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
Amoxicillin
Formulation: suspension 125mg/5 mL
Route of administration: oral
Dose regimen: 20-40mg/Kg/day administered t.i.d
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
4 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jaderson Lima, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-004002-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KETOP_L_03102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.