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Dyspepsia - Buspiron.


- candidate number0
- NTR NumberNTR48
- ISRCTNNO ISRCTN (cancelled)
- Date ISRCTN created
- date ISRCTN requested28-jul-2005
- Date Registered NTR31-mei-2005
- Secondary IDsN/A 
- Public TitleDyspepsia - Buspiron.
- Scientific TitleDoes buspiron induce a raised prolactin response in functional dyspeptics?
- ACRONYMN/A
- hypothesis
- Healt Condition(s) or Problem(s) studiedFunctional dyspepsia (FD)
- Inclusion criteriaHealthy volunteers: absence of gastrointestinal symptoms, Nepean Dyspepsia Index (NDI) score < 5, > 18 years of age. Patients: Nepean Dyspepsia Index (NDI) score >25, > 18 years of age.
- Exclusion criteriaHealthy volunteers: use of drugs that affect gastrointestinal motility (antidepressants, opiates, NSAIDís, calcium-blockers, nitrates), previous abdominal surgery, epilepsy, severe liver of renal insufficience, depression, claustrophobia, metal implants, not be able to lie down for 15 minutes. Patients: use of drugs that affect gastrointestinal motility (antidepressants, opiates, NSAIDís, calcium-blockers, nitrates), IBS, previous abdominal surgery, epilepsy, severe liver of renal insufficience, depression, claustrophobia, metal implants, not be able to lie down for 15 minutes.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jun-2005
- planned closingdate1-jun-2006
- Target number of participants20
- InterventionsSingle dose of Buspiron (30 mg).
- 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 summary10 healthy volunteers and 10 patients will be subjected to a Buspiron-Challange-Test during functional MRI. During the morning of the test blood samples will be collected (6 times 5 ml) to assess the concentration prolactin, ACTH, GH and cortisol. Furthermore, dyspeptic symptoms will be scored during the test.
- Main changes (audit trail)
- RECORD18-jul-2005 - 27-mrt-2006


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