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Dyspepsia - Dopamine.


- candidate number0
- NTR NumberNTR49
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested28-jul-2005
- Date Registered NTR18-jul-2005
- Secondary IDsN/A 
- Public TitleDyspepsia - Dopamine.
- Scientific TitleAltered central dopamine neurotransmission in Functional Dyspepsia. I An increase and/or an altered distribution?
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedFunctional dyspepsia (FD)
- Inclusion criteria1. Nepean Dyspepsia Index (NDI) score >= 25;
2. >18 years of age.
- Exclusion criteria1. Use of drugs that affect gastrointestinal motility (antidepressants, opiates, NSAIDís, calcium-blockers, nitrates);
2. use of drugs that can affect binding of the radioligand to dopamine D2 receptors (neuroleptics, dopamine D2 agonists, anti-vertigo-drugs metoclopramide, alizapride);
3. IBS;
4. previous abdominal surgery;
5. history of myocardial infarct or CVA;
6. epilepsy;
7. severe liver or renal insufficience;
8. depression;
9. claustrophobia.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-aug-2004
- planned closingdate1-jun-2006
- Target number of participants15
- InterventionsSingle dose of 185 MBq [123I]IBZM intravenously. As controlgroup an existing file of healthy male volunteers will be used.
- Primary outcome
- Secondary outcome
- Timepoints
- Trial web site
- statusstopped
- CONTACT FOR PUBLIC QUERIESDr. G.E.E. Boeckxstaens
- CONTACT for SCIENTIFIC QUERIESDr. G.E.E. Boeckxstaens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryMale patients with FD will undergo a [123I]IBZM SPECT scan to assess the number of striatal dopaminergic D2 receptors. Two hours later a brainscan (lasting 50 minutes) will be made.
- Main changes (audit trail)
- RECORD18-jul-2005 - 4-jun-2008


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