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

Zeria Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Functional Dyspepsia

Treatments

Drug: Z-338

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00761358

99010301

Details and patient eligibility

About

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.

Enrollment

820 estimated patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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)