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To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323817
First Posted: May 10, 2006
Last Update Posted: May 28, 2015
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.
Information provided by:
Zeria Pharmaceutical
  Purpose
To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia

Condition Intervention Phase
Functional Dyspepsia Drug: Z-338 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Zeria Pharmaceutical:

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

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

Estimated Enrollment: 282
Study Start Date: April 2006
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00323817


Locations
Belgium
Leuven University
Leuven, Belgium
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
Principal Investigator: Jan Tack, PhD, MD Leuven University
  More Information

ClinicalTrials.gov Identifier: NCT00323817     History of Changes
Other Study ID Numbers: 99010206E
First Submitted: May 8, 2006
First Posted: May 10, 2006
Last Update Posted: May 28, 2015
Last Verified: May 2015

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