NCT00799838终止4 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
研究概览
简要总结
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.
详细描述
The total duration of the study period per patient is 10 ± 1 day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ketoprofen + Amoxicillin
Experimental
Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
干预措施: Ketoprofen (Drug)
Ketoprofen + Amoxicillin
Experimental
Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
干预措施: Amoxicillin (Drug)
Amoxicillin
Placebo Comparator
Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
干预措施: Placebo (for Ketoprofen) (Drug)
Amoxicillin
Placebo Comparator
Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
时间窗: 24 hours
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
An investigation of heart-lung support without blood thinners during lung transplantatioIntraoperative extra-corporeal membrane oxygenation during lung transplantation for end-stage lung diseaseEUCTR2022-001697-58-ATMedical University of Vienna80
进行中（未招募）
1 期
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
进行中（未招募）
不适用
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
尚未招募
不适用
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
已完成
4 期
PET based study for early detection of inflammation and effect of treatment in psoriasisCTRI/2014/08/004842PGIMER16