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

This study has been terminated.
(Recruitment challenges despite several attenpts to increase enrollment)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00799838
First received: November 28, 2008
Last updated: October 23, 2014
Last verified: March 2014

November 28, 2008
October 23, 2014
November 2008
June 2013   (final data collection date for primary outcome measure)
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00799838 on ClinicalTrials.gov Archive Site
  • Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication [ Time Frame: 24 hours and 72 hours ] [ Designated as safety issue: No ]
  • Number of patients who used rescue medication after randomization. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • 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 ]
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pharyngotonsillitis
  • Drug: Ketoprofen

    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

  • Drug: Placebo (for Ketoprofen)

    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

  • Drug: Amoxicillin

    Formulation: suspension 125mg/5 mL

    Route of administration: oral

    Dose regimen: 20-40mg/Kg/day administered t.i.d

  • Experimental: Ketoprofen + Amoxicillin
    Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
    Interventions:
    • Drug: Ketoprofen
    • Drug: Amoxicillin
  • Placebo Comparator: Amoxicillin
    Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
    Interventions:
    • Drug: Placebo (for Ketoprofen)
    • Drug: Amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
106
June 2013
June 2013   (final data collection date for primary outcome measure)

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.

Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00799838
KETOP_L_03102, 2014-004002-15
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