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To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

This study has been completed.
Information provided by:
Zeria Pharmaceutical Identifier:
First received: May 8, 2006
Last updated: May 26, 2015
Last verified: May 2015
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual symptom [ Time Frame: 12 month ] [ Designated as safety issue: No ]

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)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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:

  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 identifier: NCT00323817

Leuven University
Leuven, Belgium
Sponsors and Collaborators
Zeria Pharmaceutical
Principal Investigator: Jan Tack, PhD, MD Leuven University
  More Information Identifier: NCT00323817     History of Changes
Other Study ID Numbers: 99010206E 
Study First Received: May 8, 2006
Last Updated: May 26, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on October 27, 2016