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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799838

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00799838     History of Changes
Other Study ID Numbers: KETOP_L_03102, 2014-004002-15
Study First Received: November 28, 2008
Last Updated: October 23, 2014
Health Authority: Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on October 29, 2014