ISRCTN74570187已完成未知
A single-center, blinded, placebo-controlled randomized study of the effect of CRX-150 on serum C-Reactive Protein (CRP) and inflammatory cytokines compared to placebo in subjects with severe adult periodontitis
CombinatorX (USA)0 个研究点目标入组 60 人开始时间: 2007年10月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •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 more than or equal to 5 mm in depth, with at least four pockets more than or equal to 6 mm. Ten percent (10%) of all pockets must bleed on probing. Subject must otherwise be in good general health.
- •3. Subject has a baseline C-reactive protein level of more than or equal to 1.5 mg/L.
- •4. Subject must have voluntarily signed the informed consent.
排除标准
- •1. Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
- •2. Subject is currently taking any anti-depressants or anti-seizure medication.
- •3. Subject has a history of seizure disorders.
- •4. Subject has a history of asthma.
- •5. Subject had a myocardial infarction within six months of enrollment.
- •6. Subject has received periodontal treatment in the last three months, including Scaling and Root Planing (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 is on concomitant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily aspirin of more than 81 mg.
- •10. Subject has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation.
- •11. Subject knowingly has HIV or Hepatitis.
- •12. Subject has undergone administration of any investigational drug within 30 days of study initiation.
- •13. Subject has history of serious drug-related reactions, including hypersensitivity to tri-cyclic anti-depressants.
- •14. Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
研究者
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