The Effect of Z-338 in Subjects With Functional Dyspepsia

Phase 2

Completed

• Conditions: Functioanl Dyspepsia

• Registration Number: NCT00458328
• Lead Sponsor: Zeria Pharmaceutical

Brief Summary

Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-10
• Primary Completion: 2009-09
• Study Completion: 2010-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-21
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 that heartburn should be the most bothersome symptom
• Subjects presenting with primary complaints relieved by stool movements (IBS)
• Subjects with diabetes by treatment
• Subjects that heartburn should be more than moderate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index

Trial Locations

Locations (1)

Kawasaki Medical School; 🇯🇵 Kurashiki, Okayama, Japan