A double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25161

Enrollment

220

Registered

2006-03-24

Start date

2006-05-01

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

functional dyspepsia

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
To determine the therapeutical effects of amitriptyline in patients with functional dyspepsia by disease specific questionnairres.	—

Secondary

Measure	Time frame
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?	—

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

None listed

Source: NL-OMON (via WHO ICTRP)