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To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00323817
First received: May 8, 2006
Last updated: June 29, 2010
Last verified: June 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323817

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

No publications provided

ClinicalTrials.gov 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:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 18, 2013