SEVERE ADULT PERIODONTITIS
Conditions
Sponsors
CombinatoRx, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: •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 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 investi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the response of CRx-139 to placebo in reducing pocket depth in subjects with severe adult periodontitis over the course of six weeks.;Secondary Objective: Evaluate the changes in inflammatory cytokines between subjects treated with CRx-139 or placebo.;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. | — |
Countries
Sweden
Outcome results
None listed