The Effect of Z-338 in Subjects With Functional Dyspepsia

The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00458328

Enrollment

Registered

2007-04-10

Start date

2007-04-30

Completion date

2010-07-31

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

Functioanl Dyspepsia

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

Interventions

DRUGZ-338

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index	—

Countries

Japan

Outcome results

None listed

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