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

June 2, 2006
January 12, 2009
April 2006
Not Provided
General impression at last visit
Same as current
Complete list of historical versions of study NCT00333372 on ClinicalTrials.gov Archive Site
  • General impression at each week
  • Individual symptom score
Same as current
Not Provided
Not Provided
 
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Functional 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
440
Not Provided
Not Provided

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
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00333372
99010207
Not Provided
Not Provided
Zeria Pharmaceutical
Not Provided
Study Director: Michio Hongo, Professor Tohoku University Hospital
Zeria Pharmaceutical
January 2009

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