E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009102 |
E.1.2 | Term | Chronic periodontitis |
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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 |
The primary criterion is the evolution of the gingival inflammation index, which will be assessed at visits D1 (inclusion), M3, M6, and M9, on natural teeth. |
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E.2.2 | Secondary objectives of the trial |
1- Assessment of papillary bleeding index 2- Depth of periodontal pocket and gum recession 3- Plaque index 4- Assessment of various inflammation markers in gingival fluid (IL-1β, MMP-1, MMP-8, TIMP-1, TNFα, TGFβ) 5- Quantification of pathogens 6- Patient and investigator's overall assessment of treatment efficacy and tolerance on a 4-point qualitative scale. The primary criterion and secondary criteria 1 through 4 will be evaluated on the patient's natural teeth. For every selected teeth, the following 6 periodontal localizations will be measured: mesiolabial, labial, distolabial, mesiolingual (or mesiopalatine), lingual (or palatine), distolingual (or distopalatine). Secondary criteria 5 & 6 will be evaluated at inclusion and upon treatment completion, on 6 sites corresponding to the 6 teeth for which the pocket depth is greatest (≥ 5mm). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female and male patients, aged 40 to 70 years, suffering from chronic periodontitis with at least 6 teeth bearing a periodontal pocket ≥ 5 mm which bleeds on probing, with at least 13 natural teeth, nonsmokers or having quit smoking for more than a year. |
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E.4 | Principal exclusion criteria |
Patients presenting with the following problems will not be included into the study: aggressive periodontitis, severe immune depression or auto-immune disorder, active or past acute or chronic severe condition of the cardiovascular system, kidneys, liver, gastro-intestinal tract, endocrine system, hematologic system, nervous system, or allergy, judged by the investigator as incompatible with the trial, coagulopathy or anticoagulant treatment, concomitant addiction interfering with the disease, hypersensitivity to Piascledine® or one of its ingredients, antibiotic treatment during the past month, nonsteroidal or steroidal anti-inflammatory treatment during the past month, or periodontal surgical treatment during the previous three months. Female patients will not be included if they are pregnant, are breast feeding, or are not making use of effective contraception. Patients will not be included if they have undergone scaling and root planing in the previous three months.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary evaluation criterion will be gingival inflammation index, evaluated as the difference between baseline and the last available assessment. Covariance analysis will be carried out on the difference, using the index at baseline as covariant, and treatment as factor. Analysis of efficacy will be done on ITT and per protocol (PP) populations.
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | No |
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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After inclusion of 136 patients plus 10 months or September 2009 |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |