Condition category
Digestive System
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/09/2011
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

Study hypothesis

Patients (stress-sensitive) with functional dyspepsia have a change in their dopaminergic system, through chronic stress, which leads to visceral hypersensitivity and therefore dyspeptic symptoms.

Ethics approval

Not provided at time of registration

Study design

Non-randomized, placebo-controlled 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 (FD)

Intervention

1. Amitriptyline or placebo for the patient group (see the amitriptyline study)
2. Single photon emission computed tomography (SPECT) imaging with radioligand (123I) iodobenzamide ([123I]IBZM)
3. Alpha-methyl-paratyrosine (AMPT/metyrosine) challenge test; 2 x 500 mg

Intervention type

Drug

Phase

Not Specified

Drug names

Amitriptyline

Primary outcome measures

To evaluate if patients with functional dyspepsia have a change in their dopaminergic system that leads to visceral hypersensitivity

Secondary outcome measures

Has amitriptyline a positive effect on those changes in the dopaminergic system through reducing the stress?

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. Take part in the amitriptyline study (ISRCTN76116512)
4. No effect on proton pump inhibitor (PPI), or a constant three-month dosage of PPI
5. No depression (Zung self-rating depression scale <50)
6. No medications which influence the intestine

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Gastroduodenal surgery
2. Reflux-like dyspepsia (Rome II criteria)
3. Use of antidepressants
4. Organic abnormalities
5. Pregnancy
6. Severe cardiac, renal, pulmonary, hepatic or systemic diseases, hyperthyroidism, glaucoma and epilepsy
7. Metal implants

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