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

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00799838

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
Acute Pharyngeal Tonsil	Drug: Ketoprofen + amoxicillin Drug: placebo + 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 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

Resource links provided by NLM:

MedlinePlus related topics: Edema Tonsils and Adenoids

Drug Information available for: Ketoprofen Amoxicillin sodium Amoxicillin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	210
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Ketoprofen+amoxicillin	Drug: Ketoprofen + amoxicillin Ten days treatment with Amoxicilin 125mg TID and ketoprofen: 1 drop/ Kg TID by oral administration
Placebo Comparator: 2 Placebo of ketoprofen+amoxicillin	Drug: placebo + amoxicillin Ten days treatment with Amoxicilin 125mg TID and placebo by oral administration

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.
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.

Contacts and Locations

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

Contacts

Contact: Trial Transparency Team

Contact-us@sanofi-aventis.com

Locations

Brazil
Sanofi-Aventis Administrative Office	Recruiting
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima, MD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00799838 History of Changes
Other Study ID Numbers:	KETOP_L_03102
Study First Received:	November 28, 2008
Last Updated:	December 21, 2011
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Ketoprofen
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2012