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Irritable Bowel Syndrome - Budesonide.


- candidate number0
- NTR NumberNTR40
- ISRCTNISRCTN31751611
- Date ISRCTN created5-aug-2005
- date ISRCTN requested18-jul-2005
- Date Registered NTR31-mei-2005
- Secondary IDsN/A 
- Public TitleIrritable Bowel Syndrome - Budesonide.
- Scientific TitleBudesonide as treatment for patients with irritable bowel syndrome.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedIrritable bowel syndrome
- Inclusion criteriaFulfilling Rome II criteria of IBS, 18-65 years of age, no other organic abnormalities explaining the complaints.
- Exclusion criteriaSevere comorbidity, pregnancy/lactation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-apr-2005
- planned closingdate1-jan-2006
- Target number of participants32
- Interventions3 mg Budesonide TID or placebo for 2 months
- Primary outcomeThe effect of budesonide on the rectal sensitivity in IBS. Participants are treated with budesonide 3 dd 3 mg or placebo during eight weeks. To assess the rectal sensitivity a barostat investigation is performed before and after the treatment-period.
- Secondary outcomeThe effect of budesonide on inflammation in rectal biopsy specimen and the effect of budesonide on IBS-symptoms.
- Timepoints
- Trial web siteN/A
- 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 Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryTreatment: 3 mg Budesonide TID or placebo for 2 months. Patients will undergo a barostat before and after treatment. Prior to the barostats 6 rectal biopsies will be taken via a proctoscope.
- Main changes (audit trail)
- RECORD13-jul-2005 - 7-dec-2006


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