A single-center, blinded, placebo-controlled randomized study of the effect of CRX-150 on serum C-Reactive Protein (CRP) and inflammatory cytokines compared to placebo in subjects with severe adult periodontitis

Not Applicable

Completed

• Conditions: Periodontitis; Digestive System

• Registration Number: ISRCTN74570187
• Lead Sponsor: CombinatorX (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-16
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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 more than or equal to 5 mm in depth, with at least four pockets more than or equal to 6 mm. Ten percent (10%) of all pockets must bleed on probing. Subject must otherwise be in good general health.
3. Subject has a baseline C-reactive protein level of more than or equal to 1.5 mg/L.
4. Subject must have voluntarily signed the informed consent.

Exclusion Criteria

1. Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
2. Subject is currently taking any anti-depressants or anti-seizure medication.
3. Subject has a history of seizure disorders.
4. Subject has a history of asthma.
5. Subject had a myocardial infarction within six months of enrollment.
6. Subject has received periodontal treatment in the last three months, including Scaling and Root Planing (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 is on concomitant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily aspirin of more than 81 mg.
10. Subject has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation.
11. Subject knowingly has HIV or Hepatitis.
12. Subject has undergone administration of any investigational drug within 30 days of study initiation.
13. Subject has history of serious drug-related reactions, including hypersensitivity to tri-cyclic anti-depressants.
14. Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.

Study & Design

• Study Type: Interventional
• Study Design: Not specified