A double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia
Not Applicable
Completed
- Conditions
- DyspepsiaFunctional dyspepsiaDigestive System
- Registration Number
- ISRCTN76116512
- Lead Sponsor
- Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)
- Brief Summary
2011 results in https://pubmed.ncbi.nlm.nih.gov/21767283/ (added 11/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
1. Age 18-65 years
2. Functional dyspepsia (Nepean Dyspepsia Index [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 antidepressants
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 questionnaires.
- Secondary Outcome Measures
Name Time Method <br> 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 separate dyspeptic symptoms?<br>