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. Identifier: NCT00323817
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : May 28, 2015
Information provided by:
Zeria Pharmaceutical

Brief Summary:
To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Z-338 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2006
Primary Completion Date : April 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Primary Outcome Measures :
  1. Global subject Outcome Assessment [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Individual symptom [ Time Frame: 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323817

Leuven University
Leuven, Belgium
Sponsors and Collaborators
Zeria Pharmaceutical
Principal Investigator: Jan Tack, PhD, MD Leuven University Identifier: NCT00323817     History of Changes
Other Study ID Numbers: 99010206E
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms