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

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Pharyngotonsillitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799838

2014-004002-15 (EudraCT Number)

KETOP_L_03102

Details and patient eligibility

About

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.

Full description

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

Enrollment: 106 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Ketoprofen + Amoxicillin

Experimental group

Description:

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

Treatment:

Drug: Amoxicillin

Drug: Ketoprofen

Amoxicillin

Placebo Comparator group

Description:

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

Treatment:

Drug: Amoxicillin

Drug: Placebo (for Ketoprofen)