No registrations found.
ID
Source
Brief title
Health condition
functional dyspepsia
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the therapeutical effects of amitriptyline in patients with functional dyspepsia by disease specific questionnairres.
Secondary outcome
1. 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?
Background summary
Treatment: 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.
Study objective
What is the therapeutical effect of amitriptyline in patients with functional dyspepsia? And have stress-sensitive patients more benefit than NOT stress-sensitive patients.
Intervention
1. Amitriptyline 1dd 12.5 mg or 25 mg or 50 mg or placebo;
2. Drinking test;
3. Stress profile (CPS and IAPS);
4. Questionnaires.
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. 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 criteria
1. 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.
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 | NL582 |
| NTR-old | NTR638 |
| Other | : N/A |
| ISRCTN | ISRCTN76116512 |