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To Evaluate the Efficacy and Safety in Subjects With 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: NCT00323817
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : May 28, 2015
Sponsor:
Information provided by:
Zeria Pharmaceutical

Tracking Information
First Submitted Date  ICMJE May 8, 2006
First Posted Date  ICMJE May 10, 2006
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE April 2006
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Global subject Outcome Assessment [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2006)
Global subject Outcome Assessment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Individual symptom [ Time Frame: 12 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2006)
Individual symptom
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
Official Title  ICMJE Not Provided
Brief Summary To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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: Z-338
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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 Completed
Estimated Enrollment  ICMJE
 (submitted: May 8, 2006)
282
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects presenting diagnosis of FD as defined by the Rome II
  • Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 NCT00323817
Other Study ID Numbers  ICMJE 99010206E
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Zeria Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Tack, PhD, MD Leuven University
PRS Account Zeria Pharmaceutical
Verification Date May 2015

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