Condition category
Digestive System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
11/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes