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)


The dopaminergic system in patients with Functional Dyspepsia analyzed by an Alpha-Methyl-Para-Tyrosine (AMPT) challenge test and Single Photon Emission Computed Tomography (SPECT) imaging before and after treatment with amitriptyline.


- candidate number2038
- NTR NumberNTR657
- ISRCTNISRCTN63226989
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR24-mrt-2006
- Secondary IDsN/A 
- Public TitleThe dopaminergic system in patients with Functional Dyspepsia analyzed by an Alpha-Methyl-Para-Tyrosine (AMPT) challenge test and Single Photon Emission Computed Tomography (SPECT) imaging before and after treatment with amitriptyline.
- Scientific TitleThe dopaminergic system in patients with Functional Dyspepsia analyzed by an Alpha-Methyl-Para-Tyrosine (AMPT) challenge test and Single Photon Emission Computed Tomography (SPECT) imaging before and after treatment with amitriptyline.
- ACRONYMSubstudy 1: Amitriptyline and the dopaminergic system
- hypothesis(stress-sensitive) Patients with functional dyspepsia have a change in the dopaminergic system, through chronic stress, what leads to visceral hypersensitivity and therefore dyspeptic symptoms.
- Healt Condition(s) or Problem(s) studiedFunctional dyspepsia (FD)
- Inclusion criteria1. Age 18-65 years; 2. Functional dyspepsia (NDI>25); 3. Take part in the amitriptyline study; 4. No effect of PPI or 3 months constantly the same doses; 5. No depression (ZUNG<50); 6. No medications which influence the intestine.
- Exclusion criteria1. Gastroduodenal surgery; 2. Reflux-like dyspepsia (Rome II criteria); 3. Use of antidepressivants; 4. Organic abnormalities; 5. Pregnancy; 6. Severe cardiac, renal, pulmonary, hepatic or systemic diseases. Hyperthyroidism, glaucoma and epilepsy; 7. Metal implantates.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-mei-2009
- Target number of participants60
- Interventions1. Amitriptyline or placebo for the patient group (see the amitriptyline study); 2. Single Photon Emission Computed Tomography (SPECT) imaging with [123I] IBZM radioligand; 3. Alpha-methyl-paratyrosine (AMPT, =metyrosine) challenge test. 2x 500 mg.
- Primary outcomeTo evaluate if patients with functional dyspepsia have a change in their dopaminergic system what leads to visceral hypersensitivity.
- Secondary outcomeHas amitriptyline a positive effect on those changes in the dopaminergic system through reducing the stress?
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G.E.E. Boeckxstaens
- CONTACT for SCIENTIFIC QUERIESDr. G.E.E. Boeckxstaens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summary40 Patients who will join the amitriptyline study can also take part to this substudy. Patients will undergo the SPECT imaging and AMPT challenge test before and at the end of the treatment with amitriptyline/placebo. 20 healthy Volunteers will get the investigations only once. With their help we want to get normal values from the dopaminergic system.
- Main changes (audit trail)
- RECORD24-mrt-2006 - 3-jul-2006


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