Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mirtazapine Versus Placebo in Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01240096
Recruitment Status : Unknown
Verified November 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : November 15, 2010
Last Update Posted : November 15, 2010
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE November 12, 2010
First Posted Date  ICMJE November 15, 2010
Last Update Posted Date November 15, 2010
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
  • 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
  • Nepean dyspepsia index for quality of life in functional dyspepsia [ Time Frame: Week 8 compared to week 0 ]
    Use of the validated NDI.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mirtazapine Versus Placebo in Functional Dyspepsia
Official Title  ICMJE Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Functional Dyspepsia
Intervention  ICMJE Drug: Mirtazapine
Mirtazapine 15 mg daily
Other Name: mirtazapine is Remergon
Study Arms  ICMJE
  • Active Comparator: Mirtazapine
    mirtazapine 15 mg daily
    Intervention: Drug: Mirtazapine
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Drug: Mirtazapine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 12, 2010)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01240096
Other Study ID Numbers  ICMJE S50181
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan Tack, M.D., Ph.D., University Hospitals Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Tack, M.D., Ph.D. Universitaire Ziekenhuizen Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP