EUCTR2004-003755-39-SE进行中（未招募）不适用
A SINGLE CENTER, SINGLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF THE EFFECT OF CRx-102 COMPARED TO PLACEBO ON SERUM C-REACTIVE PROTEIN (CRP) AND INFLAMMATORY CYTOKINES IN SUBJECTS WITH SEVERE ADULT PERIODONTITIS - CRx-102
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each subject must meet all of the following inclusion criteria to be enrolled in the study:
- •1.Subject must be between the ages of 18 and 70.
- •2.Subject must have severe periodontitis, defined as subjects with at least 10 pockets = 5 mm in depth, with at least 4 pockets between 6-9 mm. Ten percent of all pockets must bleed on probing. Subject must otherwise be in good general health.
- •3.Subject must have a baseline C-reactive protein level of = 2.5 mg/L.
- •4.Subject must have voluntarily signed the Informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- •1.Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence).
- •2.Female subjects using hormonal birth control (birth control pills, etc.) are not to be enrolled in study.
- •3.Subject is currently taking any steroids.
- •4.Subject has a history of asthma.
- •5.Subject has uncontrolled diabetes mellitus defined as a blood sugar level above 110 mg/mL.
- •6.Subject has received periodontal treatment in the last three months, including SRP, Arestin, Periochip, Atridox and/or Periostat.
- •7.Subject is currently taking a statin, and has not been on stable dosing for 6 months prior to entering into the trial.
- •8.Subject is on chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-Inflammatory drugs) within one month of Baseline Visit.
- •9.Subject has any known diseases (not including diabetes mellitus), Infections or recent surgical procedures within 30 days of study initiation.
- •10.Subject knowingly has HIV or Hepatitis.
- •11.Subject has undergone administration of any investigational drug within 30 days of study initiation.
- •12.Subject has history of serious drug-related reactions, including hypersensitivity to steroids.
- •13.Subject has limited mental capacity or language skills such that simple instructions cannot be followed or Information regarding adverse events cannot be provided.
- •14.Subject is on concomitant use of warfarin sodium, clopidogrel, ticlopidine, or once daily aspirin of more than 81 mg.
- •15. Subject has any periodontal pockets> 9mm in depth.
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