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To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00333372
First received: June 2, 2006
Last updated: January 12, 2009
Last verified: January 2009
History of Changes
  Purpose

To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.


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
Primary Purpose: Treatment
Official Title: To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by Zeria Pharmaceutical:

Primary Outcome Measures:
  • General impression at last visit

Secondary Outcome Measures:
  • General impression at each week
  • Individual symptom score

Estimated Enrollment: 440
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1
  • upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1

Exclusion Criteria:

  • subjects taht heartburn should be the most bothersome symptom
  • Subjects presenting with primary complaints relieved by stool movements (IBS)
  • Subjects with diabetes by treatment
  • Subjects taht heartburn should be more than moderate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333372

Locations
Japan
Tohoku University
Sendai, Japan
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
Study Director: Michio Hongo, Professor Tohoku University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00333372     History of Changes
Other Study ID Numbers: 99010207
Study First Received: June 2, 2006
Last Updated: January 12, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices 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 May 23, 2013