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The Effect of Z-338 in Subjects With Functional Dyspepsia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00458328
First Posted: April 10, 2007
Last Update Posted: November 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zeria Pharmaceutical
April 9, 2007
April 10, 2007
November 23, 2010
April 2007
September 2009   (Final data collection date for primary outcome measure)
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
Same as current
Complete list of historical versions of study NCT00458328 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Effect of Z-338 in Subjects With Functional Dyspepsia
The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Functioanl Dyspepsia
Drug: Z-338
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2010
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00458328
99010208
Yes
Not Provided
Not Provided
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Zeria Pharmaceutical
Not Provided
Study Chair: Ken Haruma, MD, PhD Kawasaki Medical School
Zeria Pharmaceutical
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP