Status:
COMPLETED
The Effect of Z-338 in Subjects With Functional Dyspepsia
Lead Sponsor:
Zeria Pharmaceutical
Conditions:
Functioanl Dyspepsia
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00458328
Start Date
April 1 2007
End Date
July 1 2010
Last Update
November 23 2010
Active Locations (1)
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1
Kawasaki Medical School
Kurashiki, Okayama-ken, Japan, 701-0192