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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333372

Enrollment

440

Registered

2006-06-05

Start date

2006-04-30

Completion date

Unknown

Last updated

2009-01-14

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

Conditions

Functional Dyspepsia

Brief summary

To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.

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 taht heartburn should be the most bothersome symptom * Subjects presenting with primary complaints relieved by stool movements (IBS) * Subjects with diabetes by treatment * Subjects taht heartburn should be more than moderate

Design outcomes

Primary

Measure	Time frame
General impression at last visit	—

Secondary

Measure	Time frame
General impression at each week	—
Individual symptom score	—

Countries

Japan

Outcome results

None listed

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