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: June 29, 2010
Last verified: June 2010

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

Secondary Outcome Measures:
  • Individual symptom

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
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
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

No publications provided Identifier: NCT00323817     History of Changes
Other Study ID Numbers: 99010206E
Study First Received: May 8, 2006
Last Updated: June 29, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases processed this record on April 17, 2014