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)


T-Port to apply Duodopa.


- candidate number2519
- NTR NumberNTR934
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2007
- Secondary IDs2007/072 METc
- Public TitleT-Port to apply Duodopa.
- Scientific TitleTranscutaneous port (T-Port) for gastrostomy use in combination with Duodopa.
- ACRONYMTEPODOPA
- hypothesisThe primary objective of this test series will be to gain experience and provide long-term safety using a transcutaneous titanium port as an access port for gastrostomy (T-Port) in the context of Duodopa treatment of severely afflicted PD patients.
- Healt Condition(s) or Problem(s) studiedParkinson's disease
- Inclusion criteriaClinical diagnosis of advanced Parkinson's disease. On/off phenomena leading to severe disability which can not be regulated by the normal oral drug schemes. A clinical indaction for duodenum Duodopa tretament should have been made by the treating physician.
- Exclusion criteria1. Non-responsiveness to levodopa substitution therapy;
2. Deformities abdominal wall.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mei-2007
- planned closingdate31-dec-2007
- Target number of participants10
- InterventionsInsertion in abdominal wall titanium T-Port en insertion of duodenum tube.
- Primary outcome1. To assess the safety and tolerability:
a. Adverse event monitoring;
b. Tolerability assessed by number of subjects who complete the 6 months of treatment;
c. Acceptance of the T-Port by the patients;

In addition:
2. Physical examination, including weight;
3. Vital signs systolic/diastolic blood pressure and pulse rate;
4. Concomitant medication usage;
5. Monitoring complications of the infusion device.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESprof. dr. K.L. Leenders
- CONTACT for SCIENTIFIC QUERIESprof. dr. K.L. Leenders
- Sponsor/Initiator TransCutan AB
- Funding
(Source(s) of Monetary or Material Support)
Solvay Pharmaceuticals GMBH
- PublicationsN/A
- Brief summaryThis is an open study assessing the long-term safety and utility of a new gastrostomy access port for use with Duodopa, in patients in whom a positive test of the clinical response was already conducted with Duodopa administered via a nasoduodenal tube. Only those PD patients are eligible for the T-Port system who on clinical grounds will be proposed to have Duodopa therapy.
- Main changes (audit trail)
- RECORD13-mrt-2007 - 1-feb-2010


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