A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00764374

Enrollment

412

Registered

2008-10-02

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2014-10-29

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

Conditions

Dyspepsia, Functional Dyspepsia

Keywords

YM443, Z-338, Acotiamide, Rome III, Signs and symptoms, digestive

Brief summary

To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.

Interventions

DRUGYM443

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent * postprandial fullness * early satiation * upper abdominal pain * upper abdominal discomfort * Patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (At least one symptom of either postprandial fullness or early satiation should be included.) * Patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent * upper abdominal pain * upper abdominal discomfort * postprandial fullness * bloating in the upper abdomen * early satiation * nausea * vomiting * belching * Outpatient

Exclusion criteria

* Patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, Barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent * Patient showing heartburn within 12 weeks before obtaining consent * Patient complicated by irritable bowel syndrome * Patient complicated by diabetes mellitus requiring medication * Patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life * Patient complicated by depression (including suspected cases) or sleep disturbance

Design outcomes

Primary

Measure	Time frame
Subject's global assessment	Every week

Secondary

Measure	Time frame
Disappearance rate of symptoms	Every week
Laboratory tests, resting	At 0, 4, 12, 24, 36, 48 week
12-lead ECG	At 0, 24 and 48 week
Adverse events	During treatment

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026