Contact information
Type
Scientific
Primary contact
Dr G E E Boeckxstaens
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7375
g.e.boeckxstaens@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR47
Study information
Scientific title
Effect of amitriptyline on dyspeptic symptoms assessed with the drink test in patients with functional dyspepsia
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Non-randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Amitriptyline
Primary outcome measures
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
Not provided at time of registration
Overall trial start date
01/06/2005
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/06/2005
Recruitment end date
01/06/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary