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Dyspepsia - Amitriptyline.


- candidate number0
- NTR NumberNTR47
- ISRCTNISRCTN87452036
- Date ISRCTN created5-aug-2005
- date ISRCTN requested28-jul-2005
- Date Registered NTR31-mei-2005
- Secondary IDsN/A 
- Public TitleDyspepsia - Amitriptyline.
- Scientific TitleEffect of Amitriptyline on dyspeptic symptoms assesed with the drink test in patients with functional dyspepsia.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedFunctional dyspepsia (FD)
- Inclusion criteria1. Nepean Dyspepsia Index (NDI) score >= 25,
2. no depression according Zung questionnaire, 3. > 18 and < 65 years of age,
4. drugs known to affect GI motility should be stopped at least 24 hours prior to the study.
- Exclusion criteria1. Reflux-like dyspepsia (Rome II criteria),
2. unable to stop drug intake (see inclusion criteria),
3. use of tricyclic antidepressants,
4. organic abnormalities explaining the dyspeptic complaints encountered during endoscopy or abdominal ultrasound,
5. epilepsy,
6. organic brain damage,
7. urine retention,
8. prostatic hyperplasia,
9. pyloric stenosis,
10. cardiovascular disorders, 11. hyperthyroidism,
12. liver- and kidneyfunction disorders.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jun-2005
- planned closingdate1-jun-2008
- Target number of participants100
- InterventionsSubjects will receive 25 mg Amitriptyline (25 mg) or placebo QD for 6 weeks. The dose will be doubled to 50 mg QD when there is no effect of the lower dose. In case of adverse events the dose will be halved to 12,5 mg QD.
- Primary outcome
- Secondary outcome
- Timepoints
- Trial web site
- 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 Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryPatiŽnt will undergo a drink test before and after treatment. Dyspepsia symptoms will be assessed again after treatment using the Nepean Dyspepsia Index. At the end of the trial subjects are asked to fill out the SGA (Subjectís Global Assessment), a Quality of Life questionnaire and the Zung score.
- Main changes (audit trail)
- RECORD14-jul-2005 - 5-dec-2006


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