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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00799838
First received: November 28, 2008
Last updated: March 14, 2014
Last verified: March 2014

November 28, 2008
March 14, 2014
November 2008
June 2013   (final data collection date for primary outcome measure)
Improvement in at least two of the three inflammatory signs evaluated (hyperemia, edema and pain), during the 24 first hours. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00799838 on ClinicalTrials.gov Archive Site
  • Relief of inflammatory symptoms and signs ( hyperemia, edema and pain) after 72 hs of treatment with ketoprofen drops when associated to amoxicillin; [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: From the beginning up to the end of the study. ] [ Designated as safety issue: No ]
  • Number of adverse events. [ Time Frame: From the inform consent signature up to the end of the study. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal- Tonsillitis in Pediatric Patients
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Pharyngeal Tonsil
  • Drug: Ketoprofen + amoxicillin
    Ten days treatment with Amoxicilin 125mg TID and ketoprofen: 1 drop/ Kg TID by oral administration
  • Drug: placebo + amoxicillin
    Ten days treatment with Amoxicilin 125mg TID and placebo by oral administration
  • Experimental: 1
    Ketoprofen+amoxicillin
    Intervention: Drug: Ketoprofen + amoxicillin
  • Placebo Comparator: 2
    Placebo of ketoprofen+amoxicillin
    Intervention: Drug: placebo + amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
June 2013
June 2013   (final data collection date for primary outcome measure)

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.

Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00799838
KETOP_L_03102
No
Sanofi
Sanofi
Not Provided
Study Director: Jaderson Lima, MD Sanofi
Sanofi
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP