NCT00799838
Terminated
Phase 4
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.
ConditionsPharyngotonsillitis
Overview
- Phase
- Phase 4
- Intervention
- Ketoprofen
- Conditions
- Pharyngotonsillitis
- Sponsor
- Sanofi
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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
The total duration of the study period per patient is 10 ± 1 day
Investigators
Eligibility 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.
Arms & Interventions
Ketoprofen + Amoxicillin
Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Intervention: Ketoprofen
Ketoprofen + Amoxicillin
Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Intervention: Amoxicillin
Amoxicillin
Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Intervention: Placebo (for Ketoprofen)
Amoxicillin
Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
Intervention: Amoxicillin
Outcomes
Primary Outcomes
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
Time Frame: 24 hours
Secondary Outcomes
- Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment(72 hours)
- Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication(24 hours and 72 hours)
- Number of patients who used rescue medication after randomization.(72 hours)
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
An investigation of heart-lung support without blood thinners during lung transplantatioIntraoperative extra-corporeal membrane oxygenation during lung transplantation for end-stage lung diseaseTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]EUCTR2022-001697-58-ATMedical University of Vienna80
Active, not recruiting
Phase 1
Evaluation of inflammatory markers in patients undergoing a short-term aerobic exercise program while hospitalized due to acute exacerbation of COPDChronic obstructive pulmonary disease with acute lower respiratory infectionJ44.0RBR-7yv765Faculdade de Medicina de Botucatu /UNESP
Active, not recruiting
Not Applicable
Evaluation of inflammation in patients with chronic kidney disease using a bicycle exercise program during hemodialysisKidney Chronic DiseaseC12.777.419.780.750RBR-2ybgmpBruno Medeiros Guio
Not yet recruiting
Not Applicable
Clinical manifestations and inflammatory profiles in serum and skin of patients with neutrophilic dermatoses associated with adult onset immune deficiency due to autoantibodies to Interferon-gamma (IFN-γ)Clinical manifestations and inflammatory profiles in serum and skin of patients with neutrophilic dermatoses associated with adult onset immune deficiency due to autoantibodies to Interferon-gamma (neutrophilic dermatosesautoantibody interferon-gammaskin findingscytokineschemokinesadhesion moleculesimmunoglobulin (IgG) subclassTCTR20171103001ational Research Management System : NRMS50
Completed
Phase 4
PET based study for early detection of inflammation and effect of treatment in psoriasisHealth Condition 1: null- Patients with moderate to severe psoriasisCTRI/2014/08/004842PGIMER16