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Irritable Bowel Syndrome - Ketotifen.


- candidate number0
- NTR NumberNTR39
- ISRCTNISRCTN22504486
- Date ISRCTN created5-aug-2005
- date ISRCTN requested18-jul-2005
- Date Registered NTR31-mei-2005
- Secondary IDsN/A 
- Public TitleIrritable Bowel Syndrome - Ketotifen.
- Scientific TitleThe effect of a mastcell-stabilizer on rectal sensitivity.
- 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, use of sedatives, hypnotics or antihistamines, pregnancy/lactation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2005
- planned closingdate1-jun-2006
- Target number of participants64
- Interventions2, 4 or 6 mg ketotifen BID or placebo for 2 months.
- Primary outcomeThe effect of the mastcell-stabilizer ketotifen on the rectal sensitivity in IBS.
Participants are treated with ketotifen twice daily 2-6 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 the mastcell-stabilizer ketotifen on inflammation in rectal biopsy specimen and the effect of ketotifen on IBS-symptoms.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- 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), Department of Gastroenterology
- PublicationsN/A
- Brief summaryTreatment: 2, 4 or 6 mg ketotifen BID 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 - 18-nov-2008


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