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Mirtazapine Versus Placebo in Functional Dyspepsia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Information provided by:
Universitaire Ziekenhuizen Leuven Identifier:
First received: November 12, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

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

Condition Intervention Phase
Functional Dyspepsia
Drug: Mirtazapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Difference in dyspepsia symptom scores week 8 versus week 0 [ Time Frame: Week 8 compared to week 0 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 compared to week 0 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 compared to week 0 ] [ Designated as safety issue: No ]
    Use of the validated NDI.

Estimated Enrollment: 35
Study Start Date: September 2006
Estimated Study Completion Date: December 2011
Arms Assigned Interventions
Active Comparator: Mirtazapine
mirtazapine 15 mg daily
Drug: Mirtazapine
Mirtazapine 15 mg daily
Other Name: mirtazapine is Remergon
Placebo Comparator: Placebo
Placebo once daily
Drug: Mirtazapine
Mirtazapine 15 mg daily
Other Name: mirtazapine is Remergon

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01240096

Contact: Jan Tack, M.D., Ph.D. +3216344225

University Hospitals Recruiting
Leuven, Vlaanderen, Belgium, 3000
Contact: Jan Tack, M.D., Ph.D.    +3216344225   
Principal Investigator: Jan Tack, M.D., Ph.D.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Jan Tack, M.D., Ph.D. University Hospitals Leuven
  More Information

Additional Information:
No publications provided

Responsible Party: Jan Tack, M.D., Ph.D., University Hospitals Leuven Identifier: NCT01240096     History of Changes
Other Study ID Numbers: S50181
Study First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Functional dyspepsia
Weight loss

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Stomach Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses processed this record on March 01, 2015