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
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