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
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01240096
First received: November 12, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01240096

Contacts
Contact: Jan Tack, M.D., Ph.D. +3216344225 jan.tack@med.kuleuven.be

Locations
Belgium
University Hospitals Recruiting
Leuven, Vlaanderen, Belgium, 3000
Contact: Jan Tack, M.D., Ph.D.    +3216344225    jan.tack@med.kuleuven.be   
Principal Investigator: Jan Tack, M.D., Ph.D.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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
ClinicalTrials.gov 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
Mirtazapine

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Mirtazapine
Mianserin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on July 22, 2014