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A double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia.


- candidate number2036
- NTR NumberNTR638
- ISRCTNISRCTN76116512
- Date ISRCTN created8-mei-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR24-mrt-2006
- Secondary IDsN/A 
- Public TitleA double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia.
- Scientific TitleA double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia.
- ACRONYMthe amitriptyline studie
- hypothesisWhat is the therapeutical effect of amitriptyline in patients with functional dyspepsia? And have stress-sensitive patients more benefit than NOT stress-sensitive patients.
- Healt Condition(s) or Problem(s) studiedFunctional dyspepsia (FD)
- Inclusion criteria1. Age 18-65 years; 2. Functional dyspepsia (NDI>25); 3. No effect on PPI, or 3 months constantly the same dose of PPI; 4. No medications which influence the intestine; 5. No depression (ZUNG < 50).
- Exclusion criteria1. Gastroduodenal surgery in history; 2. Reflux-like dyspepsia (Rome II criteria); 3. Use of anitdepressivants; 4. Organic abnormalities; 5. Severe cardiac, renal, pulmonary, hepatic or systemic diseases; 6. Hyperthyroidism; 7. Glaucoma and epilepsy.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-mei-2009
- Target number of participants220
- Interventions1. Amitriptyline 1dd 12.5 mg or 25 mg or 50 mg or placebo; 2. Drinking test; 3. Stress profile (CPS and IAPS); 4. Questionnaires.
- Primary outcomeTo determine the therapeutical effects of amitriptyline in patients with functional dyspepsia by disease specific questionnairres.
- Secondary outcome1. Which subgroup of patients with functional dyspepsia, stress sensitive or NOT stress sensitive, have the best benefits for the treatment with amitriptyline? 2. Does stress plays a role in the degree of the therapeutic effects? 3. What is the therapeutical effect on the seperate dyspeptic symptoms?
- Timepoints
- Trial web siteN/A
- statusplanned
- 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: amitriptyline 1 dd 25 mg or placobo for 8 weeks. After 2 weeks of treatment there will be an evaluation of the medications and if necessary the doses changes to 1 dd 12.5 mg or 1 dd 50 mg. Before start of treatment patients will get a drinking test, gastroscopie, stress profile by CPS and IAPS, and some questionnaires. During treatment patients get only questionnaires and at the end of the 8 weeks the drinking test will be repeat and the overall treatment effect will be determined.
- Main changes (audit trail)
- RECORD24-mrt-2006 - 16-jun-2006


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