Functional DyspepsiaPhase 4NCT01240096
Mirtazapine Versus Placebo in Functional Dyspepsia
A Phase 4 study testing Mirtazapine in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Mirtazapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2006to 11 Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional dyspepsia according to Rome II criteria
- Weight loss of > 5% body weights
Who cannot join
- Organic GI pathology
- History of upper gi tract surgery
- Major depression or anxiety
- Use of antidepressants in the last 2 months
- Prokinetic drugs or spasmolytic drugs
- Analgesic use (except paracetamol)
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily
Read the detailed description
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine
Two weeks run-in, 8 weeks randomized, 8 weeks open label
Assessments include
- dyspepsia questionnaire
- Nepean dyspepsia index
- Daily diary
- Vital signs
- Conditions
- Functional Dyspepsia
- Being tested
- Mirtazapine
- Keywords
- Functional dyspepsia, Weight loss, Mirtazapine
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Also called mirtazapine is Remergon
Mirtazapine 15 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Active comparator | mirtazapine 15 mg daily Receives: Drug: Mirtazapine |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in dyspepsia symptom scores week 8 versus week 0
The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998).
Measured: Week 8 compared to week 0
Secondary outcomes (2)
Individual symptom severities
Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint
Measured: Week 8 compared to week 0
Nepean dyspepsia index for quality of life in functional dyspepsia
Use of the validated NDI.
Measured: Week 8 compared to week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study start1 Sep 2006
- Primary completion1 Aug 2011
- Study completion11 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Jan Tack, M.D., Ph.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240096
- Sponsor's protocol ID
- S50181
- Status last verified
- Jun 2024
- First submitted
- 12 Nov 2010
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Tack J, Ly HG, Carbone F, Vanheel H, Vanuytsel T, Holvoet L, Boeckxstaens G, Caenepeel P, Arts J, Van Oudenhove L. Efficacy of Mirtazapine in Patients With Functional Dyspepsia and Weight Loss. Clin Gastroenterol Hepatol. 2016 Mar;14(3):385-392.e4. doi: 10.1016/j.cgh.2015.09.043. Epub 2015 Oct 30.
PubMed 26538208
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss
- ClinicalTrials.gov ID
- NCT01240096
- Acronym / sponsor ID
- S50181
- Conditions
- Functional Dyspepsia
- Keywords
- Functional dyspepsia, Weight loss, Mirtazapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Sep 2006 (actual)
- Primary completion
- 1 Aug 2011 (actual)
- Study completion
- 11 Sep 2012 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily
Detailed description
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine
Two weeks run-in, 8 weeks randomized, 8 weeks open label
Assessments include
- dyspepsia questionnaire
- Nepean dyspepsia index
- Daily diary
- Vital signs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Active comparator | Drug: Mirtazapinemirtazapine 15 mg daily |
| Placebo | Placebo comparator | Drug: MirtazapinePlacebo once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Functional dyspepsia according to Rome II criteria
- Weight loss of > 5% body weights
Key exclusion criteria (7 listed)
- Organic GI pathology
- History of upper gi tract surgery
- Major depression or anxiety
- Use of antidepressants in the last 2 months
- Prokinetic drugs or spasmolytic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirtazapineAlso: mirtazapine is RemergonMirtazapine 15 mg daily | Drug | Mirtazapine, Placebo |
Primary outcome
Difference in dyspepsia symptom scores week 8 versus week 0
Time frame: Week 8 compared to week 0
The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998).
2 secondary outcomes
Individual symptom severities
Time frame: Week 8 compared to week 0
Nepean dyspepsia index for quality of life in functional dyspepsia
Time frame: Week 8 compared to week 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 26538208Tack J, Ly HG, Carbone F, Vanheel H, Vanuytsel T, Holvoet L, Boeckxstaens G, Caenepeel P, Arts J, Van Oudenhove L. Efficacy of Mirtazapine in Patients With Functional Dyspepsia and Weight Loss. Clin Gastroenterol Hepatol. 2016 Mar;14(3):385-392.e4. doi: 10.1016/j.cgh.2015.09.043. Epub 2015 Oct 30.
- Website Research GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, M.D., Ph.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirtazapine in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in dyspepsia symptom scores week 8 versus week 0 (time frame: Week 8 compared to week 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.