NCT00668746已完成4 期
Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- OraPharma
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
研究概览
简要总结
This study will look at the safety of using the study medicine for a long time. It will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time.
详细描述
The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. This will be assessed through monitoring the total number and proportion of minocycline-resistant bacteria and the identity of minocycline-resistant species within a panel of 40 representative periodontal species in saliva and subgingival plaque.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •generally healthy
- •over 25 years of age
- •moderate-to-severe chronic periodontitis
- •documented informed consent
- •willing to comply with contraceptive requirements
- •free from any significant oral soft tissue pathology
排除标准
- •willing to adhere to prohibitions and restrictions of the study
- •oral health inappropriate for study inclusion
- •females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
- •reporting any of the following conditions:
- •allergy to a tetracycline-class drug
- •systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
- •active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- •diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
- •participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
- •employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
- •anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
研究组 & 干预措施
Minocycline HCl microspheres
Experimental
Minocycline HCl microspheres
干预措施: Minocycline HCl microspheres (Drug)
结局指标
主要结局
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
时间窗: from Baseline to Day 30 and Day 180
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
次要结局
- Micocycline-Resistance From Plaque Samples(Baseline, Day 30 and Day 180)
- Micocycline-Resistance From Saliva Sample(Baseline, Day 30 and Day 180)
研究者
研究点 (1)
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