Condition category
Digestive System
Date applied
20/05/2007
Date assigned
16/10/2007
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco D'Aiuto

ORCID ID

Contact details

Periodontology Unit
UCL Eastman Dental Institute
256 Grays Inn Road
London
WC1X 8LD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRx-150-001-01

Study information

Scientific title

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

http://www.combinatorx.com/

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

Publication citations

Additional files

Editorial Notes