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

Phase 2

Completed

• Conditions: Functional Dyspepsia

• Registration Number: NCT00333372
• Lead Sponsor: Zeria Pharmaceutical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-05
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-12
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
General impression at last visit

Secondary Outcome Measures

Name	Time	Method
General impression at each week
Individual symptom score

Trial Locations

Locations (1)

Tohoku University; 🇯🇵 Sendai, Japan