Severe adult periodontitis
Conditions
Interventions
Trade Name: Persantin® 100 mg and
Prednisolone BP 1 mg
Product Name: NA
Product Code: CRx-102
Pharmaceutical Form: Tablet
INN or Proposed INN: Dipyridamole & prednisolone
CAS Number: NA
Current Spons
Sponsors
CombinatoRx, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the response of CRx-102 against placebo in lowering CRP levels in subjects with severe adult over the course of six weeks.;Secondary Objective: •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 ;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 | — |
Countries
Sweden
Outcome results
None listed