Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CRx-150-001-01
Study information
Scientific title
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
Acronym
Perio-04-17
Study hypothesis
This study aims to assess the effect of CRx-150 (amoxapine and dipyridamole) on serum C-Reactive Protein (CRP) and inflammatory cytokines compared to placebo in adult with severe periodontitis. This is both the first study of the anti-inflammatory effects of CRx-150 in a subject population with a chronic inflammation, and also the first study of this combination in human.
Ethics approval
University College London Hospital Ethics Committee alpha, ref: 04/Q0505/58
Study design
Single-center blinded placebo-controlled randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Periodontitis
Intervention
Daily CRx-150 (150 mg amoxapine and 200 mg dipridamole) administered orally or placebo for 8 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
CRx-150 (amoxapine and dipyridamole)
Primary outcome measures
Reduction in CRP levels in subjects with severe adult periodontitis treated with CRx-150 compared to placebo over the course of six weeks.
Secondary outcome measures
1. Changes in inflammatory cytokine profiles, measured at each visit, 10 visits in total during the intervention
2. Change in periodontal pocket depths between baseline and 8 weeks
3. Changes in CRP levels following SRP, measured between Visit 7 and 8
Overall trial start date
01/09/2004
Overall trial end date
01/03/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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.
Recruitment start date
01/09/2004
Recruitment end date
01/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Periodontology Unit
London
WC1X 8LD
United Kingdom
Sponsor information
Organisation
CombinatorX (USA)
Sponsor details
650 Albany Street
Boston
02118
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
CombinatorX (USA)
Alternative name(s)
CombinatoRx
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary