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The effect of H1 receptor antagonist on rectal sensitivity


- candidate number3314
- NTR NumberNTR1320
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-mei-2008
- Secondary IDsfex1 2008-003348-12
- Public TitleThe effect of H1 receptor antagonist on rectal sensitivity
- Scientific TitleThe effect of H1 receptor antagonist on rectal sensitivity
- ACRONYMN/A
- hypothesisInhibition of the H1 receptor will lead to an improvement of rectal sensitivity, followed by less abdominal symptoms in patients with irritable bowel syndrome.
- Healt Condition(s) or Problem(s) studiedIrritable bowel syndrome, H1 receptor antagonist
- Inclusion criteria1. 18-65 years
2. Patients have to meet the Rome Criteria for IBS
- Exclusion criteria1. Severe comorbidity like DM, kidneydiseases, liverdiseases cardiovasculair diseases.
2. Major abdominal surgery in history.
3. Use of antihistaminica, hypnotics or sedative medication
4. Pregnancy or breastfeeding
5. Indepandancy of alcohol
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2008
- planned closingdate1-mei-2010
- Target number of participants60
- InterventionsDuring 8 weeks patients with IBS will recieved a treatment with Fexofenadine, an H1 receptor antagonist, or placebo.
The first 2 weeks 180 mg/day, then 6 weeks 360 mg/day. Before start and end of the study a barostat investigation will be performed for measuring the rectal sensitivity.
- Primary outcomeEffect of Fexofenadine on rectal sensitivity in IBS patients
- Secondary outcomeImprovement of abdominal symptoms and qualty of life in IBS patients
- Timepoints12 weeks trial. 2 weeks screening, 8 weeks of treatment and 2 weeks foolow up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhDfellow B. Braak
- CONTACT for SCIENTIFIC QUERIESDr. G.E.E. Boeckxstaens
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIrritable Bowel disease is a functional bowel disorder with a high prevalence, caracterized by low respons on regular therapy and most of the time a poor quality of life. Previeus studies have shown that hypersensitivity of the rectum, measured by barostat, is one explanation of developping abdominal symptoms. This hypersensitivity is probably caused by the mastcell. A study with a mastcell stabilizator ketotifen reduced the rectal hypersensitivity and symptomsscore. However there was no change in mastcell activity seen, suggesting that the effect of ketotifen is due to H1 receptor antagonism. The aim of this study is to investigated if fexofenadine, a specific H1 receptor antagonist, will reduced rectal sensitivity and secondairy will lead to improvement of symptoms and quality of life.
IBS patients who will meet the Rome III Criteria will be randomized in a double blind placebo controlled trial with 8 weeks of treatment with 180-360 mg fexofenadine a day. Before and at the end of the treatment a barostat investigation will be performed for measuring the rectal sensititivity.
- Main changes (audit trail)
- RECORD22-mei-2008 - 28-mei-2008


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