A double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia

ISRCTN	ISRCTN76116512
DOI	https://doi.org/10.1186/ISRCTN76116512
Protocol serial number	NL582, NTR638
Sponsor	Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)
Funder	Academic Medical Center (AMC)

Submission date: 08/05/2006
Registration date: 08/05/2006
Last edited: 11/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G.E.E. Boeckxstaens
Scientific

Academic Medical Center (AMC)
Department of Gastroenterology, C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5667375
Email	g.e.boeckxstaens@amc.uva.nl

Study information

Primary study design	Interventional
Study design	A double-blind, placebo controlled, randomized study
Secondary study design	Randomised controlled trial
Scientific title	A double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsia
Study acronym	The amitriptyline study
Study objectives	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(s)	Ethics approval not received as of 08/05/2006.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Amitriptyline
Primary outcome measure(s)	To determine the therapeutical effects of amitriptyline in patients with functional dyspepsia by disease specific questionnaires.
Key secondary outcome measure(s)	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?
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	220
Total final enrolment	38
Key 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)
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	01/05/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011	11/01/2021	Yes	No

Editorial Notes

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.