Overview

To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zeria Pharmaceutical
Treatments:
Z 338
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 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