Condition category
Digestive System
Date applied
08/05/2006
Date assigned
08/05/2006
Last edited
08/05/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The amitriptyline study

Study hypothesis

What is the therapeutical effect of amitriptyline in patients with functional dyspepsia? Have stress-sensitive patients more benefit than non stress-sensitive patients?

Ethics approval

Ethics approval not received as of 08/05/2006.

Study design

A double-blind, placebo controlled, randomized study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Functional dyspepsia

Intervention

1. Amitriptyline 1 dd 12.5 mg or 25 mg or 50 mg or placebo
2. Drinking test
3. Stress profile (CPS and IAPS)
4. Questionnaires

Intervention type

Drug

Phase

Not Specified

Drug names

Amitriptyline

Primary outcome measures

To determine the therapeutical effects of amitriptyline in patients with functional dyspepsia by disease specific questionnaires.

Secondary outcome measures

1. Which subgroup of patients with functional dyspepsia, stress sensitive or not stress sensitive have the best benefits for the treatment with amitriptyline?
2. Does stress plays a role in the degree of the therapeutic effects?
3. What is the therapeutical effect on the separate dyspeptic symptoms?

Overall trial start date

01/05/2006

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-65 years
2. Functional dyspepsia (Nepean Dyspepsia Index [NDI] >25)
3. No effect on PPI, or 3 months constantly the same dose of PPI
4. No medications which influence the intestine
5. No depression (ZUNG <50)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Gastroduodenal surgery in history
2. Reflux-like dyspepsia (Rome II criteria)
3. Use of antidepressants
4. Organic abnormalities
5. Severe cardiac, renal, pulmonary, hepatic or systemic diseases
6. Hyperthyroidism
7. Glaucoma and epilepsy

Recruitment start date

01/05/2006

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Academic Medical Center (AMC)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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