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-102 against placebo in lowering CRP levels in subjects with severe adult over the course of six weeks. |
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E.2.2 | Secondary objectives of the trial |
•Evaluate the changes in Inflammatory cytokine profiles between subjects treated with CRx-102 or placebo.
•Evaluate the efficacy of CRx-102 in reducing periodontal pocket depths
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal exclusion criteria |
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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E.5 End points |
E.5.1 | Primary end point(s) |
• Reduction in CRP levels in subjects with severe adult periodontitis treated with CRx-102 compared to placebo 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 | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | No |
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 | |