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The Effect of Z-338 in Subjects With Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00458328
First received: April 9, 2007
Last updated: November 21, 2010
Last verified: November 2010
History of Changes
  Purpose

Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound


Condition Intervention Phase
Functioanl 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: The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by Zeria Pharmaceutical:

Primary Outcome Measures:
  • Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index

Estimated Enrollment: 40
Study Start Date: April 2007
Study Completion Date: July 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  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 that heartburn should be the most bothersome symptom
  • Subjects presenting with primary complaints relieved by stool movements (IBS)
  • Subjects with diabetes by treatment
  • Subjects that heartburn should be more than moderate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458328

Locations
Japan
Kawasaki Medical School
Kurashiki, Okayama, Japan, 701-0192
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
Study Chair: Ken Haruma, MD, PhD Kawasaki Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00458328     History of Changes
Other Study ID Numbers: 99010208
Study First Received: April 9, 2007
Last Updated: November 21, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013