To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

Phase 2

Completed

• Conditions: Functional Dyspepsia

• Registration Number: NCT00323817
• Lead Sponsor: Zeria Pharmaceutical

Brief Summary

To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-10
• Primary Completion: 2009-04
• Study Completion: 2009-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Subjects presenting diagnosis of FD as defined by the Rome II
• Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global subject Outcome Assessment	12 month

Secondary Outcome Measures

Name	Time	Method
Individual symptom	12 month

Trial Locations

Locations (1)

Leuven University; 🇧🇪 Leuven, Belgium