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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharyngotonsillitis

Intervention: Ketoprofen (Drug); Placebo (for Ketoprofen) (Drug); Amoxicillin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Sanofi

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


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, 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.

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

Primary outcome: Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment

Secondary outcome:

Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment

Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication

Number of patients who used rescue medication after randomization.

Detailed description: The total duration of the study period per patient is 10 1 day


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


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.

Locations and Contacts

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

Starting date: November 2008
Last updated: October 23, 2014

Page last updated: August 23, 2015

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