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

Phase 3

Completed

• Conditions: Functional Dyspepsia
• Interventions: Drug: Placebo; Drug: Z-338

• Registration Number: NCT00761358
• Lead Sponsor: Zeria Pharmaceutical

Brief Summary

The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-29
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-21
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

• Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent
• Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)
• Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent

Exclusion Criteria

• Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent
• Subjects have heartburn in last 12 weeks before obtaining informed consent
• Subjects with irritable bowel disease (IBS)
• Subjects with diabetes mellitus requiring treatment
• Subjects with serious anxiety disorder
• Subjects with depression and/or sleep disorder
• Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
Z-338	Z-338	-

Primary Outcome Measures

Name	Time	Method
General impression at last visit in treatment period	4 week
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period	4 week

Secondary Outcome Measures

Name	Time	Method
Individual symptom score	Every week
SF-NDI	At 0, 4 week and 4 week after treatment
General Impression	Every week
Laboratory tests	At 0, 4 week and 4 week after treatment
Adverse Event	4 week treatment period and 4 week after treatment