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
Secondary identifying numbers NTR47
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

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 566 7375
Email g.e.boeckxstaens@amc.uva.nl

Study information

Study designNon-randomised controlled parallel group trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEffect of amitriptyline on dyspeptic symptoms assessed with the drink test in patients with functional dyspepsia
Study objectivesTo 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) studiedFunctional dyspepsia
InterventionSubjects 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Amitriptyline
Primary outcome measurePatient 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 measuresNot provided at time of registration
Overall study start date01/06/2005
Completion date01/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2005
Date of final enrolment01/06/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
University/education

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

University/education

Academic Medical Centre (AMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan