What is the therapeutical effect of amitriptyline in patients with functional dyspepsia? And have stress-sensitive patients more benefit than NOT stress-sensitive patients.
ID
Bron
Verkorte titel
Aandoening
functional dyspepsia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To determine the therapeutical effects of amitriptyline in patients with functional dyspepsia by disease specific questionnairres.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
What is the therapeutical effect of amitriptyline in patients with functional dyspepsia? And have stress-sensitive patients more benefit than NOT stress-sensitive patients.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL582 |
| NTR-old | NTR638 |
| Ander register | : N/A |
| ISRCTN | ISRCTN76116512 |