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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Pharyngotonsillitis
• Intervention / Treatment: Drug: Ketoprofen; Drug: Amoxicillin; Drug: Placebo (for Ketoprofen)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ketoprofen + Amoxicillin; Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days	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; Drug: Amoxicillin; Formulation: suspension 125mg/5 mL Route of administration: oral Dose regimen: 20-40mg/Kg/day administered t.i.d
PLACEBO_COMPARATOR: Amoxicillin; Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days	Drug: Amoxicillin; Formulation: suspension 125mg/5 mL Route of administration: oral Dose regimen: 20-40mg/Kg/day administered t.i.d; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment	24 hours

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: November 28, 2008
• First Submitted That Met QC Criteria: November 28, 2008
• First Posted (ESTIMATE): December 1, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anti-Bacterial Agents; Amoxicillin; Ketoprofen
• Other Study ID Numbers: KETOP_L_03102; 2014-004002-15 (EUDRACT_NUMBER)