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
  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:


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
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: 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 September 30, 2014