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

This study has been completed.
Information provided by:
Zeria Pharmaceutical Identifier:
First received: June 2, 2006
Last updated: January 12, 2009
Last verified: January 2009
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
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:

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

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00333372

Tohoku University
Sendai, Japan
Sponsors and Collaborators
Zeria Pharmaceutical
Study Director: Michio Hongo, Professor Tohoku University Hospital
  More Information Identifier: NCT00333372     History of Changes
Other Study ID Numbers: 99010207
Study First Received: June 2, 2006
Last Updated: January 12, 2009

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases processed this record on May 24, 2017