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

Pharyngotonsillitis Clinical Trial

— DROPS  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00799838
• Other study ID #: KETOP_L_03102
• Secondary ID: 2014-004002-15
• Status: Terminated
• Phase: Phase 4
• First received: November 28, 2008
• Last updated: October 23, 2014
• Start date: November 2008
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Description:

The total duration of the study period per patient is 10 ± 1 day

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngotonsillitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment		24 hours	No
Secondary	Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment		72 hours	No
Secondary	Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication		24 hours and 72 hours	No
Secondary	Number of patients who used rescue medication after randomization.		72 hours	No