search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A phase I/II, double blind, cross-over design, placebo controlled, pilot study to assess the effect and tolerability of multiple oral doses of phytosphingosine in Sjögren’s patients.


- candidate number6000
- NTR NumberNTR1879
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jun-2009
- Secondary IDsPHS-01 UMCG
- Public TitleA phase I/II, double blind, cross-over design, placebo controlled, pilot study to assess the effect and tolerability of multiple oral doses of phytosphingosine in Sjögren’s patients.
- Scientific TitleA phase I/II, double blind, cross-over design, placebo controlled, pilot study to assess the effect and tolerability of multiple oral doses of phytosphingosine in Sjögren’s patients.
- ACRONYMOral Hygiene Xerostomia
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedXerostomia, Candida albicans, Sjogren's disease
- Inclusion criteria1. Primary Sjögren’s syndrome female adult patients, diagnosed following EU criteria [1];
2. Stimulated whole salivary flow rate >0.30 ml/min, stimulated parotid salivary >0.15 ml/min;
3. Saliva positive for S. mutants and C. albicans (all m.o. cfu≥103);
4. Not pregnant;
5. No use of xerogenic drugs or drugs that might affect oral ecology;
6. Willing and able to adhere to the study visit schedule and other protocol requirements;
7. Written informed consent signed.
- Exclusion criteria1. Use of antibiotic medication less than 3 weeks before screening;
2. Dentures;
3. Smoking;
4. Current or history of drug and/or alcohol abuse;
5. In parallel participation in another trial with an investigational product.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2010
- Target number of participants20
- InterventionsSingle treatment with pastilles containing phytosphingosine or placebo. Wash out period at least 14 days.
- Primary outcomeReduction in C. albicans and or S. mutans relative to control.
- Secondary outcomeTolerability.
- TimepointsOne hour treatment repeated crossed over after 14 days.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. A. Vissink
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A. Vissink
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Oral and Maxillofacial Surgery
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-jun-2009 - 10-mei-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl