NCT00242281已完成3 期
A Phase III, Multicenter Study to Evaluate the Safety/Efficacy of APC-111 MP Tablet QD vs. Penicillin VK QID Both for 10 Days Treatment of Pharyngitis Secondary to S.Pyogenes in Adolescents/Adults
Advancis Pharmaceutical Corporation41 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 41
- 主要终点
- The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.
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
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent/assent
- •Age 12 and older
- •A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following:
- •Odynophagia
- •Tonsillar or pharyngeal exudates
- •Tender cervical lymph nodes
- •Fever or history of fever treated with antipyretics
- •Uvular edema
- •Elevated white blood cell count
- •Red tongue and prominent papillae
- •A positive rapid screening test for S. pyogenes
- •Subject is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms
- •Females must be non-lactating and:
- •At no risk of pregnancy for one of the following reasons: post-menopausal for at least one year, hysterectomy, tubal ligation, or abstinent from sexual activity that could result in pregnancy, OR
- •If of child-bearing potential and sexually active, the patient must have a negative baseline urine pregnancy test and be utilizing acceptable contraceptives throughout the study.
- •If of child bearing potential and not currently sexually active, the patient must have a negative baseline urine pregnancy test and must agree to remain abstinent for the duration of the study. If they decide to become sexually active during the period of the study, they must agree to use acceptable contraception.
- •Are able to comply with the requirements of the protocol
排除标准
- •Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology
- •More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit
- •Pharyngitis known or suspected to be due to a pathogen resistant to β-lactam antimicrobials
- •Subjects who are known carriers of S. pyogenes
- •Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the β-lactam class of antimicrobials, including cephalosporins
- •Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:
- •Any rapidly progressive underlying disease with a shortened life expectancy
- •The inability to swallow the study dosage form
- •Unable to understand the requirements of the study
- •Neutropenia (<1000 PMNs/mm3) or other immunocompromised state.
- •Concurrent condition of upper/lower respiratory tract infections
- •Concurrent symptoms of viral etiology including:
- •conjunctivitis, coryza, and cough
- •diffuse adenopathy or rash suggestive of mononucleosis
- •rash or arthropathy suggestive of scarlet fever
- •Seizure disorder, lowered seizure threshold, or psychiatric condition requiring use of major tranquilizers
- •Pregnancy or nursing
- •Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study
- •Current drug or alcohol abuse
- •Receipt of any experimental drug or medical device within the previous 30 days
- •Previous treatment under this protocol
- •The need for hospitalization or I.V. antimicrobial therapy
- •Previous systemic antimicrobial therapy within 30 days
- •The presence of clinically significant hematologic conditions
- •History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes or previous rheumatic fever
- •Probenecid treatment or systemic steroids for 7 days prior to baseline visit and throughout the duration of the study
结局指标
主要结局
The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)
次要结局
- The bacteriological outcome at the Late Post Therapy visit (Day 38-45)
- Clinical Outcome at TOC and LPT
- Safety
研究者
研究点 (41)
Loading locations...
相似试验
已完成
3 期
APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep ThroatPharyngitisTonsillitisNCT00095368Advancis Pharmaceutical Corporation500
已完成
3 期
Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep MycosisDeep MycosisNCT03471988Asahi Kasei Pharma Corporation103
招募中
3 期
Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal CancerColon or Upper Rectum AdenocarcinomaNCT06197425Centre Hospitalier Universitaire Dijon1,660
招募中
3 期
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingNCT06408259Bristol-Myers Squibb194
已完成
3 期
PH94B Nasal Spray for Anxiety Induced by a Public Speaking ChallengeSocial Anxiety DisorderNCT04754802VistaGen Therapeutics, Inc.224