Mirtazapine Versus Placebo in Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Mirtazapine
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional dyspepsia, Weight loss, Mirtazapine
Eligibility Criteria
Inclusion Criteria:
- Functional dyspepsia according to Rome II criteria
- Weight loss of > 5% body weights
Exclusion Criteria:
- 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
Sites / Locations
- University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mirtazapine
Placebo
Arm Description
mirtazapine 15 mg daily
Placebo once daily
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Individual symptom severities
Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint
Nepean dyspepsia index for quality of life in functional dyspepsia
Use of the validated NDI.
Full Information
NCT ID
NCT01240096
First Posted
November 12, 2010
Last Updated
November 12, 2010
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01240096
Brief Title
Mirtazapine Versus Placebo in Functional Dyspepsia
Official Title
Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Functional dyspepsia, Weight loss, Mirtazapine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mirtazapine
Arm Type
Active Comparator
Arm Description
mirtazapine 15 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Other Intervention Name(s)
mirtazapine is Remergon
Intervention Description
Mirtazapine 15 mg daily
Primary Outcome Measure Information:
Title
Difference in dyspepsia symptom scores week 8 versus week 0
Description
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).
Time Frame
Week 8 compared to week 0
Secondary Outcome Measure Information:
Title
Individual symptom severities
Description
Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint
Time Frame
Week 8 compared to week 0
Title
Nepean dyspepsia index for quality of life in functional dyspepsia
Description
Use of the validated NDI.
Time Frame
Week 8 compared to week 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Functional dyspepsia according to Rome II criteria
Weight loss of > 5% body weights
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Tack, M.D., Ph.D.
Phone
+3216344225
Email
jan.tack@med.kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, M.D., Ph.D.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals
City
Leuven
State/Province
Vlaanderen
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Tack, M.D., Ph.D.
Phone
+3216344225
Email
jan.tack@med.kuleuven.be
First Name & Middle Initial & Last Name & Degree
Jan Tack, M.D., Ph.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26538208
Citation
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.
Results Reference
derived
Links:
URL
http://www.targid.eu
Description
Website Research Group
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Mirtazapine Versus Placebo in Functional Dyspepsia
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