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 |
| Secondary identifying numbers | NL582, NTR638 |
- 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
Scientific
Academic Medical Center (AMC)
Department of Gastroenterology, C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5667375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Study design | A double-blind, placebo controlled, randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amitriptyline |
| Primary outcome measure | 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 study start date | 01/05/2006 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)
University/education
University/education
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
University/education
Academic Medical Center (AMC)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
