Overview

The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To assess in subjects with and without functional dyspepsia the effects of Z-338 on: 1. Type and severity of symptoms a standardized nutrient challenge 2. The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge 3. The association of the above with the manifestations of symptoms and symptom pattern
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Zeria Pharmaceutical
Treatments:
Z 338
Criteria
Inclusion Criteria:

1. Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII
criteria and three or more moderate symptoms of Gastrointestinal Score

2. Subjects with no history of functional dyspepsia Clinical assessment, physical
examination and laboratory testing without evidence for relevant abnormality.

Other protocol-defined inclusion/exclusion criteria may apply.