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

Information source: Sanofi
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Pharyngeal Tonsil

Intervention: Ketoprofen + amoxicillin (Drug); placebo + amoxicillin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Jaderson Lima, MD, Study Director, Affiliation: Sanofi

Overall contact:
Trial Transparency Team, Email: Contact-us@sanofi-aventis.com

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.

Clinical Details

Official title: Local Study, National (Brazil), Phase IV, Multicentric, Double-blind, Randomized, Parallel, With Two Arms of Treatment, Controlled by Placebo, for for Evaluation of the Inflammatory Symptoms Reduction in the Treatment of Acute Bacterial Pharyngeal Tonsillitis 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: Improvement in at least two of the three inflammatory signs evaluated (hyperemia, edema and pain), during the 24 first hours.

Secondary outcome:

Relief of inflammatory symptoms and signs ( hyperemia, edema and pain) after 72 hs of treatment with ketoprofen drops when associated to amoxicillin;

Percentage of children in both arms that used paracetamol as rescue medication (fever or pain) after the randomization; - Safety ( adverse events reported by the investigators)

Number of adverse events.

Eligibility

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Quick-test positive for Streptococcus pyogenes.

- Pain (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 crosses from 4;

- Fever in the previous 48 hours;

- Cervical adenomegaly;

- Tonsilla with erythema.

Exclusion Criteria:

- History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions.

- History and laboratorial confirmation of hematologic, hepatic or renal disorders.

- Use of NSAIDs 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.

Locations and Contacts

Trial Transparency Team, Email: Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Sao Paulo, Brazil; Recruiting
Additional Information

Starting date: November 2008
Last updated: July 16, 2012

Page last updated: February 07, 2013

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