E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SEVERE ADULT PERIODONTITIS |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Compare the response of CRx-139 to placebo in reducing pocket depth in subjects with severe adult periodontitis over the course of six weeks. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the changes in inflammatory cytokines between subjects treated with CRx-139 or placebo. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•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.
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E.4 | Principal exclusion criteria |
•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 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Compare the response of CRx-139 to placebo in pocket depth reduction in subjects with severe adult periodontitis over the course of six weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |