Dyspepsia - amitriptyline: effect of amitriptyline on dyspeptic symptoms assessed with the drink test in patients with functional dyspepsia
| ISRCTN | ISRCTN87452036 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87452036 |
| Protocol serial number | NTR47 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 11/06/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G E E Boeckxstaens
Scientific
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised controlled parallel group trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Effect of amitriptyline on dyspeptic symptoms assessed with the drink test in patients with functional dyspepsia |
| Study objectives | To assess the effect of amitriptyline on dyspeptic symptoms assessed with the drink test in patients with functional dyspepsia. Please note that as of 8th May 2006: This trial did not go ahead. It was started again with a different design. The new trial is registered under ISRCTN76116512, http://www.controlled-trials.com/ISRCTN76116512. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Functional dyspepsia |
| Intervention | Subjects will receive 25 mg amitriptyline (25 mg) or placebo once a day (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 halved to 12.5 mg QD. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amitriptyline |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
