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

This study is currently recruiting participants.

Verified April 2013 by Sanofi

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00799838

First received: November 28, 2008

Last updated: April 16, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2008

Last Updated Date

April 16, 2013

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00799838 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Local Study, National (Brazil), Phase IV, Multicentric, Double-blind, Randomized, Parallel, With Two Arms of Treatment, Controlled by Placebo, for for Evaluation of the Inflammatory Symptoms Reduction in the Treatment of Acute Bacterial Pharyngeal Tonsillitis With Ketoprofen and Amoxicillin in Pediatric Patients

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Pharyngeal Tonsil

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Ketoprofen+amoxicillin

Intervention: Drug: Ketoprofen + amoxicillin
Placebo Comparator: 2
Placebo of ketoprofen+amoxicillin

Intervention: Drug: placebo + amoxicillin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

210

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

4 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Trial Transparency Team

Contact-us@sanofi-aventis.com

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00799838

Other Study ID Numbers ^ICMJE

KETOP_L_03102

Has Data Monitoring Committee

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jaderson Lima, MD

Sanofi

Information Provided By

Sanofi

Verification Date

April 2013

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

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