EUCTR2005-001440-23-SE进行中（未招募）不适用
A SINGLE CENTER, BLINDED, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF THE EFFECT OF CRx-139 ON POCKET DEPTH AND INFLAMMATORY CYTOKINES COMPARED TO PLACEBO IN SUBJECTS WITH SEVERE ADULT PERIODONTITIS - CRx-139-PE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Subject must be at least 20 years of age.
- •Subject must have severe periodontitis, defined as subjects with at least 10 pockets = 5 mm in depth, with at least four pockets of 6-9 mm. Ten percent (10%) of all pockets must bleed on probing. Subject must otherwise be in good general health.
- •Subject must have a baseline C-reactive protein level of = 1.8 mg/L indicated by high sensitivity CRP test.
- •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
- •Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (i.e., an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence).
- •Female subjects using hormonal birth control (birth control pills, etc.) are not to be enrolled.
- •Subject is currently taking any steroids, anti-depressants or anti-seizure medications.
- •Subject has a history of seizure disorders.
- •Subject has a history of a psychiatric disorder such as bipolar disorder, schizophrenia, or anxiety disorder.
- •Subject has impaired liver function defined by AST or ALT ? 2 times the ULN.
- •Subject has impaired kidney function defined by a serum creatinine level ? 1.4 or creatinine clearance < 30 mL/min.
- •Subject has a history of ventricular tachycardia or episodes of unstable angina pectoris.
- •Subject has had an acute myocardial infarction or cerebrovascular accident within one year prior to entering the study.
- •Subject has had coronary artery bypass grafting or percutaneous transluminal coronary angioplasty within six months prior to entering the study.
- •Subject has a history of glaucoma.
- •Subject has an increased bleeding risk, or is being treated with compounds known to increase bleeding such as NSAIDs, clopidogrel, ticlopidine or dipyridamole.
- •Subject is actively abusing alcohol, hallucinogens or other addictive agents.
- •Subject has received periodontal treatment in the last three months, including SRP, Arestin, Periochip, Atridox and/or Periostat.
- •Subject has undergone periodontal surgery within the last 12 months.
- •Subject is currently taking a statin, and has not been on stable dosing for 6 months prior to entering into the trial.
- •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, warfarin sodium, and non-steroidal anti-inflammatory drugs) within one month of Baseline Visit.
- •Subject has uncontrolled diabetes mellitus defined as a blood sugar level above 110 mg/mL.
- •Subject has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation.
- •Subject knowingly has HIV or Hepatitis.
- •Subject has undergone administration of any investigational drug within 30 days of study initiation.
- •Subject has history of serious drug-related reactions, including hypersensitivity to steroids or Selective Serotonin Reuptake Inhibitors (SSRI).
- •Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
- •Subject has any periodontal pockets > 9 mm in depth.
- •Subject is currently taking a statin, and has not been on stable dosing for 6 months prior to entering into the trial.
- •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, warfarin sodium, and non-steroidal anti-inflammatory drugs) within one month of Baseline Visit.
- •Subject has uncontrolled diabetes mellitus defined as a blood sugar level above 110 mg/mL.
- •Subject has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation.
- •Subject knowingly has HIV or Hepatitis.
- •Subject has undergone administration of any investi
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