Dyspepsia - Amitriptyline.

Effect of Amitriptyline on dyspeptic symptoms assesed with the drink test in patients with functional dyspepsia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25606

Enrollment

100

Registered

2005-05-31

Start date

2005-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Inclusion criteria

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

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.

Contacts

Public ContactG.E.E. Boeckxstaens

Academic Medical Center (AMC), Department of Gastroenterology, C2-328, P.O. Box 22660

g.e.boeckxstaens@amc.uva.nl+31 (0)20 5667375

Outcome results