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ISRCTN
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ISRCTN53060944
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ClinicalTrials.gov identifier
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Public title
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Evaluation of the mucosa-permeability of the stomach measured by the Ussing Chambers technique in patients with functional dyspepsia before and after treatment with amitriptyline
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Through stress, the mast cells become activated, and by their vaso-active substances the mucosa permeability will become increased. Therefore the mucosa is easier to penetrate by microbes and acid. This increased permeability will lead to hypersensitivity, inflammation and pain.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Non-randomized controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Functional dyspepsia (FD)
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Participants - inclusion criteria
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1. Age 18-65 years
2. Patients have to take part in the amitriptyline study (ISRCTN76116512)
3. Functional dyspepsia (Nepean dyspepsia index [NDI] >25)
4. No depression (Zung self-rating depression scale <50)
5. No effect on proton pump inhibitor (PPI), or a constant three-month dosage of PPI
6. No medications which will influence the intestine
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Participants - exclusion criteria
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1. Gastroduodenal surgery in history
2. Reflux-like dyspepsia (Rome II criteria)
3. Use of antidepressants
4. Organic abnormalities
5. Severe cardiac, renal, pulmonary, hepatic, or systemic diseases, hyperthyroidism, glaucoma and epilepsy
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Anticipated start date
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01/05/2006
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Anticipated end date
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01/05/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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1. Patients: amitriptyline or placebo (see amitriptyline study)
2. Gastroscopy with biopsy
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Primary outcome measure(s)
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To show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.
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Secondary outcome measure(s)
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1. Is there a difference between healthy volunteers and patients with functional dyspepsia?
2. Amitriptyline has a positive effect on the mucosa permeability by reducing the level of stress and the dyspeptic symptoms will be improved
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Sources of funding
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Academic Medical Center (AMC)
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Trial website
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Publications
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Contact name
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Dr
G.E.E.
Boeckxstaens
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Address
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Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 5667375
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Fax
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+31 (0)20 6917033
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Email
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g.e.boeckxstaens@amc.uva.nl
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Sponsor
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Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)
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Address
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P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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07/06/2006
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Last edited
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07/09/2011
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Date ISRCTN assigned
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07/06/2006
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