- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240096
Mirtazapine Versus Placebo in Functional Dyspepsia
November 12, 2010 updated by: Universitaire Ziekenhuizen KU Leuven
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
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
35
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaanderen
-
Leuven, Vlaanderen, Belgium, 3000
- Recruiting
- University Hospitals
-
Contact:
- Jan Tack, M.D., Ph.D.
- Phone Number: +3216344225
- Email: jan.tack@med.kuleuven.be
-
Principal Investigator:
- Jan Tack, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo once daily
|
Mirtazapine 15 mg daily
Other Names:
|
Active Comparator: Mirtazapine
mirtazapine 15 mg daily
|
Mirtazapine 15 mg daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Week 8 compared to week 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual symptom severities
Time Frame: Week 8 compared to week 0
|
Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint
|
Week 8 compared to week 0
|
Nepean dyspepsia index for quality of life in functional dyspepsia
Time Frame: Week 8 compared to week 0
|
Use of the validated NDI.
|
Week 8 compared to week 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
November 12, 2010
First Submitted That Met QC Criteria
November 12, 2010
First Posted (Estimate)
November 15, 2010
Study Record Updates
Last Update Posted (Estimate)
November 15, 2010
Last Update Submitted That Met QC Criteria
November 12, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Dyspepsia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Mirtazapine
Other Study ID Numbers
- S50181
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Zeria PharmaceuticalRecruitingFunctional DyspepsiaJapan
-
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-
Seoul National University HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
Wonju Severance Christian HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
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-
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-
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-
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