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
| ISRCTN | ISRCTN74570187 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74570187 |
| Secondary identifying numbers | CRx-150-001-01 |
- Submission date
- 20/05/2007
- Registration date
- 16/10/2007
- Last edited
- 14/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Francesco D'Aiuto
Scientific
Scientific
Periodontology Unit
UCL Eastman Dental Institute
256 Grays Inn Road
London
WC1X 8LD
United Kingdom
Study information
| Study design | Single-center blinded placebo-controlled randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Study acronym | Perio-04-17 |
| Study objectives | 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(s) | University College London Hospital Ethics Committee alpha, ref: 04/Q0505/58 |
| Health condition(s) or problem(s) studied | Periodontitis |
| Intervention | Daily CRx-150 (150 mg amoxapine and 200 mg dipridamole) administered orally or placebo for 8 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | CRx-150 (amoxapine and dipyridamole) |
| Primary outcome measure | 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 study start date | 01/09/2004 |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Periodontology Unit
London
WC1X 8LD
United Kingdom
WC1X 8LD
United Kingdom
Sponsor information
CombinatorX (USA)
Industry
Industry
650 Albany Street
Boston
02118
United States of America
| Website | http://www.combinatorx.com/ |
|---|---|
"ROR" |
https://ror.org/0496m6d18 |
Funders
Funder type
Industry
CombinatorX (USA)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- CombinatoRx
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/03/2017: No publications found in PubMed, verifying study status with principal investigator
