A double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia.
- Conditions
- functional dyspepsia
- Registration Number
- NL-OMON25161
- Lead Sponsor
- Academic Medical Center (AMC) Amsterdam, Department gastroenterology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 220
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the therapeutical effects of amitriptyline in patients with functional dyspepsia by disease specific questionnairres.
- Secondary Outcome Measures
Name Time Method 1. Which subgroup of patients with functional dyspepsia, stress sensitive or NOT stress sensitive, have the best benefits for the treatment with amitriptyline?<br>2. Does stress plays a role in the degree of the therapeutic effects?<br>3. What is the therapeutical effect on the seperate dyspeptic symptoms?