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

Phase 2

Completed

• Conditions: Dyspepsia

• Registration Number: NCT00298194
• Lead Sponsor: Zeria Pharmaceutical

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study First Posted: 2006-03-01
• Primary Completion: 2008-07
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-12
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (1)

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia