No registrations found.
ID
Source
Brief title
Intervention
Background summary
Patiënt 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 (Subject’s Global Assessment), a Quality of Life questionnaire and the Zung score.
Study objective
N/A
Intervention
Subjects 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.
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL27 |
| NTR-old | NTR47 |
| Other | : N/A |
| ISRCTN | ISRCTN87452036 |