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

To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00761358

Enrollment

820

Registered

2008-09-29

Start date

2008-09-30

Completion date

2010-08-31

Last updated

2010-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Keywords

Acotiamide

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.

Interventions

DRUGZ-338

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

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)

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026