Dyspepsia - amitriptyline: effect of amitriptyline on dyspeptic symptoms assessed with the drink test in patients with functional dyspepsia
Completed
- Conditions
- Functional dyspepsiaDigestive SystemDyspepsia
- Registration Number
- ISRCTN87452036
- Lead Sponsor
- Academic Medical Centre (AMC) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Nepean Dyspepsia Index (NDI) score greater than or equal to 25
2. No depression according to Zung questionnaire
3. Aged greater than 18 and less than 65 years
4. Drugs known to affect gastrointestinal (GI) motility should be stopped at least 24 hours prior to the study
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, liver- and kidney-function disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient will undergo a drink test before and after treatment. Dyspepsia symptoms will be assessed again after treatment using the Nepean Dyspepsia Index. At the end of the trial subjects are asked to fill out the Subject's Global Assessment (SGA), a Quality of Life questionnaire and the Zung score.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration