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
  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:


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
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 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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014