Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharyngotonsillitis
Intervention: Ketoprofen (Drug); Placebo (for Ketoprofen) (Drug); Amoxicillin (Drug)
Phase: Phase 4
Sponsored by: Sanofi
Official(s) and/or principal investigator(s):
Jaderson Lima, MD, Study Director, Affiliation: Sanofi
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
Official title: Local, Phase IV, Multicenter, Double-blind, Randomized, Parallel, With Two Treatment Arms, Placebo-controlled Study to Evaluate the Reduction of Inflammatory Symptoms in the Treatment of Bacterial Pharyngitis With Ketoprofen and Amoxicillin in Pediatric Patients.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment
Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication
Number of patients who used rescue medication after randomization.
The total duration of the study period per patient is 10 ± 1 day
Minimum age: 4 Years.
Maximum age: 11 Years.
- Quick-test positive for Streptococcus pyogenes;
- Indication for treatment with amoxicillin according to labeling and physician's
- 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.
- 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
- 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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Sao Paulo, Brazil
Starting date: November 2008
Last updated: October 23, 2014