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

NCT00799838 | Terminated Phase 4

• 2 other identifiers: KETOP_L_031022014-004002-15
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharyngotonsillitis

Outcome Measures

Primary Outcomes (1)

• Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment

  24 hours

Secondary Outcomes (3)

• 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

Study Arms (2)

Ketoprofen + Amoxicillin

EXPERIMENTAL

Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days

Drug: Ketoprofen; Drug: Amoxicillin

Amoxicillin

PLACEBO COMPARATOR

Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days

Drug: Placebo (for Ketoprofen); Drug: Amoxicillin

Interventions

Ketoprofen DRUG

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

Ketoprofen + Amoxicillin

Placebo (for Ketoprofen) DRUG

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

Amoxicillin DRUG

Formulation: suspension 125mg/5 mL Route of administration: oral Dose regimen: 20-40mg/Kg/day administered t.i.d

Amoxicillin; Ketoprofen + Amoxicillin

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

MeSH Terms

Interventions

Ketoprofen; Amoxicillin

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jaderson Lima, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 24, 2014

Record last verified: 2014-03

Locations

BR (1)