Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients

Phase 4

Terminated

• Conditions: Pharyngotonsillitis
• Interventions: Drug: Ketoprofen; Drug: Placebo (for Ketoprofen); Drug: Amoxicillin

• Registration Number: NCT00799838
• Lead Sponsor: Sanofi

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

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-28
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoprofen + Amoxicillin	Amoxicillin	Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Ketoprofen + Amoxicillin	Ketoprofen	Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Amoxicillin	Placebo (for Ketoprofen)	Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Amoxicillin	Amoxicillin	Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days

Primary Outcome Measures

Name	Time	Method
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇧🇷 Sao Paulo, Brazil