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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:
ClinicalTrials.gov Identifier:
NCT00799838
First Posted: December 1, 2008
Last Update Posted: January 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose
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.

Condition Intervention Phase
Pharyngotonsillitis Drug: Ketoprofen Drug: Placebo (for Ketoprofen) Drug: Amoxicillin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment [ Time Frame: 72 hours ]
  • Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication [ Time Frame: 24 hours and 72 hours ]
  • Number of patients who used rescue medication after randomization. [ Time Frame: 72 hours ]

Enrollment: 106
Study Start Date: November 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketoprofen + Amoxicillin
Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
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: Amoxicillin

Formulation: suspension 125mg/5 mL

Route of administration: oral

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

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


Detailed Description:
The total duration of the study period per patient is 10 ± 1 day
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799838


Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima, MD Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00799838     History of Changes
Other Study ID Numbers: KETOP_L_03102
2014-004002-15 ( EudraCT Number )
First Submitted: November 28, 2008
First Posted: December 1, 2008
Last Update Posted: January 23, 2015
Last Verified: March 2014

Additional relevant MeSH terms:
Amoxicillin
Ketoprofen
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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